Dose Range Study of CD5789 in Acne Vulgaris

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01616654
• Collaborator: (none)
• Enrollment: 304
• Locations: 24
• Arms: 5
• Actual Duration (Months): 23.7
• Patients Per Site: 12.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: CD5789 25 µg/g cream; Drug: CD5789 50 µg/g cream; Drug: CD5789 100 µg/g cream; Drug: Tazarotene 0.1% gel; Drug: Vehicle cream	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris
• Actual Study Start Date: Jun 20, 2012
• Actual Primary Completion Date: Jul 24, 2013
• Actual Study Completion Date: Jun 12, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD5789 25 mcg/g Cream Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.	Drug: CD5789 25 µg/g cream; CD5789 25 µg/g cream applied once daily
Experimental: CD5789 50 mcg/g Cream Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.	Drug: CD5789 50 µg/g cream; CD5789 50 µg/g cream applied once daily
Active Comparator: CD5789 100 mcg/g Cream Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.	Drug: CD5789 100 µg/g cream; CD5789 100 µg/g cream applied once daily
Placebo Comparator: Tazarotene 0.1% Gel Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Drug: Tazarotene 0.1% gel; Tazarotene 0.1% gel applied once daily
Experimental: Vehicle Cream Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.	Drug: Vehicle cream; Vehicle cream applied once daily

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Success Rate 1 (SR1) [From Baseline at Week 12]

   Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).

2. Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF) [Baseline, Week 12]

   The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.

3. Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF) [Baseline, Week 12]

   The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.

Secondary Outcome Measures

1. Percentage of Participants With Success Rate 2 (SR2) [From Baseline to Week 12]

   Success Rate 2 (SR2) was defined as the percentage of participants rated "Clear" (Grade 0) or "Almost clear" (Grade 1) with at least a two-point reduction on the IGA scale from Baseline to Week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by LOCF.

2. Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF) [Baseline, Week 12]

   The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF.

3. Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF) [Baseline, Week 12]

   The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF. Percent changes in lesion counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female participant, 12 to 35 years old with the following characteristics:

• Facial acne severity grade of the following:

• Stratum 1: IGA score of 3 or 4

• Stratum 2: IGA score of 4

• Stratum 3: IGA score of 3 or 4

• A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:

• Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.

• Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.

• Stratum 3: Participants of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.

• Note: Participants of Japanese origin will not be included in Stratum 1 or Stratum 2. Japanese origin is defined as all four grandparents were born in Japan.

Exclusion Criteria:

• The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)

• Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant participates in the clinical trial.

• Known or suspected allergies or sensitivities to any components of any of the study drugs.

• Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama	United States	35205
2	Parexel Early Phase	Glendale	California	United States	91206
3	Odyssey Medispa	Marina Del Rey	California	United States	90292
4	Rady Children's Hospital	San Diego	California	United States	92123
5	FXM Research Corp Miami	Miami	Florida	United States	33175
6	FMX Research Miramar	Miramar	Florida	United States	33027
7	Meda Phase, Inc	Newnan	Georgia	United States	30263
8	Deaconess Clinic, Inc.	Evansville	Indiana	United States	47713
9	Dermatology Specialists PC	Louisville	Kentucky	United States	40202
10	Hamzavi Dermatology	Fort Gratiot	Michigan	United States	48059
11	Somerset Skin Centre	Troy	Michigan	United States	48084
12	Skin Specialists, PC	Omaha	Nebraska	United States	68144
13	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
14	Zoe Drealos, MD	High Point	North Carolina	United States	27262
15	PMG Research of Wilmington	Wilmington	North Carolina	United States	28401
16	Central Sooner Research	Norman	Oklahoma	United States	73069
17	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
18	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina	United States	29607
19	Arlington Center for Dermatology	Arlington	Texas	United States	76011
20	Suzanne Bruce and Associates P.A. The Center for Skin Research	Houston	Texas	United States	77056
21	Stephen Miller MD	San Antonio	Texas	United States	78229
22	Center for Clinical Studies	Webster	Texas	United States	77598
23	Dermatology Research Center	Salt Lake City	Utah	United States	84124
24	The Education & Research Foundation, Inc.	Lynchburg	Virginia	United States	24501

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Michael Graeber, M.D., Galderma R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01616654
• Other Study ID Numbers: RD.06.SPR.18223
• First Posted: Jun 12, 2012
• Last Update Posted: Sep 20, 2021
• Last Verified: Aug 1, 2021

• Additional relevant MeSH terms: Acne Vulgaris; Tazarotene; Trifarotene

Study Results

Participant Flow

Recruitment Details

The study was conducted in United States. A total of 422 participants were screened between 20 June 2012 to 01 May 2013. Of which, 118 were screen failures. Screen failures were mainly due to inclusion criteria not met. A total of 304 participants were randomized in the study.

Pre-assignment Detail

Participants randomized were stratified according to ethnic origin, acne severity & number of lesions as: Stratum 1: Non-Japanese, Investigator's Global Assessment (IGA) of 3/4, >= 20 but <= 40 inflammatory and >=30 non-inflammatory lesions and <=1 nodule on face; Stratum 2: Non-Japanese, IGA of 4, >40 inflammatory & >= 30 non-inflammatory lesions and <=4 nodules on face; Stratum 3: Japanese origin, IGA of 3 or 4, >= 20 inflammatory & >= 30 non-inflammatory lesions & <= 4 nodules on face.

Arm/Group Title	CD5789 25 mcg/g Cream	CD5789 50 mcg/g Cream	CD5789 100 mcg/g Cream	Tazarotene 0.1% Gel	Vehicle Cream
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Period Title: Overall Study
STARTED	61	61	60	61	61
COMPLETED	56	53	50	53	49
NOT COMPLETED	5	8	10	8	12

Baseline Characteristics

Arm/Group Title	CD5789 25 mcg/g Cream	CD5789 50 mcg/g Cream	CD5789 100 mcg/g Cream	Tazarotene 0.1% Gel	Vehicle Cream	Total
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.	Total of all reporting groups
Overall Participants	61	61	60	61	61	304
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	18.1 (5.26)	18.2 (4.76)	18.3 (5.59)	18.3 (4.83)	18.3 (4.84)	18.2 (5.03)
Sex: Female, Male (Count of Participants)
Female	15 24.6%	8 13.1%	12 20%	17 27.9%	13 21.3%	65 21.4%
Male	46 75.4%	53 86.9%	48 80%	44 72.1%	48 78.7%	239 78.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	2 3.3%	0 0%	2 0.7%
Asian	0 0%	2 3.3%	0 0%	0 0%	1 1.6%	3 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	9 14.8%	7 11.5%	8 13.3%	12 19.7%	13 21.3%	49 16.1%
White	52 85.2%	51 83.6%	52 86.7%	47 77%	47 77%	249 81.9%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 1.6%	0 0%	0 0%	0 0%	1 0.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Success Rate 1 (SR1)
Description	Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Time Frame	From Baseline at Week 12

Outcome Measure Data

Analysis Population Description

Analysis was performed on Intent to treat (ITT) population that included all subjects who were randomized and to whom study drug was dispensed.

Arm/Group Title	CD5789 25 mcg/g Cream	CD5789 50 mcg/g Cream	CD5789 100 mcg/g Cream	Tazarotene 0.1% Gel	CD5789 Vehicle Cream
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Measure Participants	61	61	60	61	61
Number [percentage of participants]	29.51 48.4%	32.79 53.8%	26.67 44.5%	32.79 53.8%	16.39 26.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CD5789 25 mcg/g Cream, CD5789 Vehicle Cream
	Comments	The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.096
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	13.115
	Confidence Interval	(2-Sided) 95%; -3.266 to 29.495
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CD5789 50 mcg/g Cream, CD5789 Vehicle Cream
	Comments	The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.040
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	16.393
	Confidence Interval	(2-Sided) 95%; -0.249 to 33.036
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CD5789 100 mcg/g Cream, CD5789 Vehicle Cream
	Comments	The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.184
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	10.273
	Confidence Interval	(2-Sided) 95%; -5.923 to 26.470
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tazarotene 0.1% Gel, CD5789 Vehicle Cream
	Comments	The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.041
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	16.393
	Confidence Interval	(2-Sided) 95%; -0.249 to 33.036
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
Description	The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	CD5789 25 mcg/g Cream	CD5789 50 mcg/g Cream	CD5789 100 mcg/g Cream	Tazarotene 0.1% Gel	Vehicle Cream
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Measure Participants	61	61	60	61	61
Least Squares Mean (Standard Error) [lesion count]	-53.61 (8.314)	-54.75 (8.261)	-54.99 (8.296)	-59.84 (8.301)	-46.87 (7.934)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CD5789 25 mcg/g Cream, CD5789 Vehicle Cream
	Comments	Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.108
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-6.74
	Confidence Interval	(2-Sided) 95%; -14.96 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CD5789 50 mcg/g Cream, CD5789 Vehicle Cream
	Comments	Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.060
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-7.88
	Confidence Interval	(2-Sided) 95%; -16.11 to 0.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CD5789 100 mcg/g Cream, CD5789 Vehicle Cream
	Comments	Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.054
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-8.11
	Confidence Interval	(2-Sided) 95%; -16.35 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tazarotene 0.1% Gel, CD5789 Vehicle Cream
	Comments	Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-12.97
	Confidence Interval	(2-Sided) 95%; -21.18 to -4.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
Description	The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	CD5789 25 mcg/g Cream	CD5789 50 mcg/g Cream	CD5789 100 mcg/g Cream	Tazarotene 0.1% Gel	CD5789 Vehicle Cream
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Measure Participants	61	61	60	61	61
Mean (Standard Deviation) [percentage change]	-47.59 (28.474)	-49.87 (24.731)	-50.72 (24.885)	-55.07 (26.295)	-40.48 (28.968)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CD5789 25 mcg/g Cream, CD5789 Vehicle Cream
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.067
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CD5789 50 mcg/g Cream, CD5789 Vehicle Cream
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.054
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CD5789 100 mcg/g Cream, CD5789 Vehicle Cream
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.038
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Tazarotene 0.1% Gel, CD5789 Vehicle Cream
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

4. Secondary Outcome

Title	Percentage of Participants With Success Rate 2 (SR2)
Description	Success Rate 2 (SR2) was defined as the percentage of participants rated "Clear" (Grade 0) or "Almost clear" (Grade 1) with at least a two-point reduction on the IGA scale from Baseline to Week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by LOCF.
Time Frame	From Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	CD5789 25 mcg/g Cream	CD5789 50 mcg/g Cream	CD5789 100 mcg/g Cream	Tazarotene 0.1% Gel	Vehicle Cream
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Measure Participants	61	61	60	61	61
Number [percentage of participants]	13.11 21.5%	14.75 24.2%	16.67 27.8%	21.31 34.9%	8.20 13.4%

5. Secondary Outcome

Title	Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Description	The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	CD5789 25 mcg/g Cream	CD5789 50 mcg/g Cream	CD5789 100 mcg/g Cream	Tazarotene 0.1% Gel	CD5789 Vehicle Cream
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Measure Participants	61	61	60	61	61
Inflammatory Lesions	-19.67 (14.874)	-21.11 (13.268)	-19.32 (11.566)	-21.03 (13.890)	-17.74 (15.073)
Non-inflammatory Lesions	-24.30 (21.633)	-18.69 (12.895)	-23.70 (18.390)	-28.26 (26.346)	-17.70 (17.745)

6. Secondary Outcome

Title	Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)
Description	The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 1 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). All missing values were imputed by LOCF. Percent changes in lesion counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Analysis was performed on ITT population.

Arm/Group Title	CD5789 25 mcg/g Cream	CD5789 50 mcg/g Cream	CD5789 100 mcg/g Cream	Tazarotene 0.1% Gel	CD5789 Vehicle Cream
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.	Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.	Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Measure Participants	61	61	60	61	61
Inflammatory lesion count	-49.16 (35.711)	-53.14 (30.187)	-51.93 (27.255)	-53.09 (29.484)	-41.70 (35.898)
Non-inflammatory lesion count	-46.34 (30.888)	-45.26 (29.331)	-49.57 (29.786)	-55.88 (28.913)	-38.20 (30.368)

Adverse Events

Time Frame	Adverse events (AEs) that occurred on or after the first dose of study medication through Week 14 Follow-up visit.
Adverse Event Reporting Description	The safety population was defined as the ITT population participants who applied/were administered the study drug(s) at least once.
Arm/Group Title	CD5789 25 mcg/g Cream		CD5789 50 mcg/g Cream		CD5789 100 mcg/g Cream		Tazarotene 0.1% Gel		CD5789 Vehicle Cream
Arm/Group Description	Participants randomized in stratum 1, 2 and 3 were applied with 25 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.		Participants randomized in stratum 1, 2 and 3 were applied with 50 microgram per gram (mcg/g) CD5789 50 once daily for 12 weeks.		Participants randomized in stratum 1, 2 and 3 were applied with 100 microgram per gram (mcg/g) CD5789 cream, once daily for 12 weeks.		Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.		Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
All Cause Mortality
	CD5789 25 mcg/g Cream		CD5789 50 mcg/g Cream		CD5789 100 mcg/g Cream		Tazarotene 0.1% Gel		CD5789 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		0/61 (0%)		0/60 (0%)		0/61 (0%)		0/61 (0%)
Serious Adverse Events
	CD5789 25 mcg/g Cream		CD5789 50 mcg/g Cream		CD5789 100 mcg/g Cream		Tazarotene 0.1% Gel		CD5789 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/61 (1.6%)		1/61 (1.6%)		0/60 (0%)		0/61 (0%)		1/61 (1.6%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/61 (1.6%)	1	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Psychiatric disorders
Depression	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Other (Not Including Serious) Adverse Events
	CD5789 25 mcg/g Cream		CD5789 50 mcg/g Cream		CD5789 100 mcg/g Cream		Tazarotene 0.1% Gel		CD5789 Vehicle Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/61 (24.6%)		17/61 (27.9%)		23/60 (38.3%)		24/61 (39.3%)		18/61 (29.5%)
Blood and lymphatic system disorders
Lymphadenopathy	1/61 (1.6%)	1	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Cardiac disorders
Atrioventricular block first degree	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Bradycardia	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Right ventricular hypertrophy	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Sinus arrhythmia	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Sinus bradycardia	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Eye disorders
Conjunctivitis	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Eye haemorrhage	1/61 (1.6%)	1	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Gastrointestinal disorders
Abdominal discomfort	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Cheilitis	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Diarrhoea	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Nausea	1/61 (1.6%)	1	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Tooth impacted	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Toothache	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
General disorders
Pain	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Pyrexia	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Immune system disorders
Allergy to arthropod bite	1/61 (1.6%)	2	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Seasonal allergy	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Infections and infestations
Nasopharyngitis	4/61 (6.6%)	4	1/61 (1.6%)	1	5/60 (8.3%)	5	5/61 (8.2%)	5	1/61 (1.6%)	1
Upper respiratory tract infection	2/61 (3.3%)	2	3/61 (4.9%)	3	4/60 (6.7%)	4	1/61 (1.6%)	1	6/61 (9.8%)	6
Influenza	1/61 (1.6%)	1	0/61 (0%)	0	2/60 (3.3%)	2	0/61 (0%)	0	0/61 (0%)	0
Infectious mononucleosis	0/61 (0%)	0	1/61 (1.6%)	1	1/60 (1.7%)	1	0/61 (0%)	0	0/61 (0%)	0
Folliculitis	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Furuncle	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Gastroenteritis	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Rhinitis	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Sinusitis	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Streptococcal infection	1/61 (1.6%)	1	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Subcutaneous abscess	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Urinary tract infection	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Injury, poisoning and procedural complications
Excoriation	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	2/61 (3.3%)	2	0/61 (0%)	0
Muscle strain	0/61 (0%)	0	1/61 (1.6%)	1	1/60 (1.7%)	1	0/61 (0%)	0	0/61 (0%)	0
Concussion	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Joint sprain	0/61 (0%)	0	0/61 (0%)	0	1/60 (1.7%)	1	0/61 (0%)	0	0/61 (0%)	0
Muscle injury	0/61 (0%)	0	0/61 (0%)	0	1/60 (1.7%)	1	0/61 (0%)	0	0/61 (0%)	0
Overdose	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Skin laceration	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Wound	1/61 (1.6%)	1	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Investigations
Electrocardiogram abnormal	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	2/61 (3.3%)	2
Alanine aminotransferase decreased	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Bilirubin conjugated increased	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Blood alkaline phosphatase increased	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Blood bilirubin increased	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Blood glucose increased	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Blood uric acid decreased	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Electrocardiogram ST segment elevation	1/61 (1.6%)	1	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Electrocardiogram T wave inversion	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Red blood cell count decreased	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Musculoskeletal and connective tissue disorders
Myalgia	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Pain in extremity	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Nervous system disorders
Headache	2/61 (3.3%)	3	2/61 (3.3%)	2	1/60 (1.7%)	1	1/61 (1.6%)	1	3/61 (4.9%)	3
Tension headache	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Psychiatric disorders
Depression	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Oppositional defiant disorder	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	2/61 (3.3%)	2	0/61 (0%)	0	1/60 (1.7%)	1	1/61 (1.6%)	1	0/61 (0%)	0
Cough	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Skin and subcutaneous tissue disorders
Skin irritation	0/61 (0%)	0	0/61 (0%)	0	6/60 (10%)	7	5/61 (8.2%)	5	0/61 (0%)	0
Pruritus	0/61 (0%)	0	0/61 (0%)	0	2/60 (3.3%)	2	1/61 (1.6%)	1	0/61 (0%)	0
Skin burning sensation	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	2/61 (3.3%)	2	0/61 (0%)	0
Dermatitis	0/61 (0%)	0	0/61 (0%)	0	1/60 (1.7%)	1	1/61 (1.6%)	1	0/61 (0%)	0
Erythema	0/61 (0%)	0	0/61 (0%)	0	1/60 (1.7%)	1	1/61 (1.6%)	1	0/61 (0%)	0
Pain of skin	0/61 (0%)	0	0/61 (0%)	0	1/60 (1.7%)	1	1/61 (1.6%)	1	0/61 (0%)	0
Pityriasis alba	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	2/61 (3.3%)	2	0/61 (0%)	0
Rash	1/61 (1.6%)	1	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Skin exfoliation	0/61 (0%)	0	0/61 (0%)	0	1/60 (1.7%)	1	1/61 (1.6%)	1	0/61 (0%)	0
Dry skin	1/61 (1.6%)	1	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Dyshidrosis	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	1/61 (1.6%)	1	0/61 (0%)	0
Eczema	0/61 (0%)	0	1/61 (1.6%)	1	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0
Skin hypopigmentation	0/61 (0%)	0	0/61 (0%)	0	1/60 (1.7%)	1	0/61 (0%)	0	0/61 (0%)	0
Urticaria	0/61 (0%)	0	0/61 (0%)	0	1/60 (1.7%)	1	0/61 (0%)	0	0/61 (0%)	0
Urticaria papular	0/61 (0%)	0	0/61 (0%)	0	0/60 (0%)	0	0/61 (0%)	0	1/61 (1.6%)	1
Vascular disorders
Hypertension	0/61 (0%)	0	1/61 (1.6%)	2	0/60 (0%)	0	0/61 (0%)	0	0/61 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide his draft of such publication to sponsor to review and approve at least 2 months prior to the date of intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.