Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01880320
• Collaborator: (none)
• Enrollment: 503
• Locations: 31
• Arms: 3
• Duration (Months): 8
• Patients Per Site: 16.2
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The study hypothesis are based on the assumption that :

• CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects

• CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: CD0271 0.3% / CD1579 2.5%; Drug: CD0271 0.1% / CD1579 2.5%; Drug: Topical Gel Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 503 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD0271 0.3% /CD1579 2.5% Gel active arm	Drug: CD0271 0.3% / CD1579 2.5%
Active Comparator: CD0271 0.1% / CD1579 2.5% Comparator arm	Drug: CD0271 0.1% / CD1579 2.5%
Placebo Comparator: Topical Gel Vehicle Placebo arm	Drug: Topical Gel Vehicle

Outcome Measures

Primary Outcome Measures

1. Success Rate [Week 12]

   Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.

2. Changes From Baseline in Inflammatory Lesion Counts [Baseline - Week12]

3. Changes From Baseline in Non-Inflammatory Lesion Counts [Baseline - Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female, who is 12 years of age or older at Screening visit.

2. Clinical diagnosis of acne vulgaris with facial involvement.

3. An IGA of Moderate (3) or Severe (4) at Baseline visit.

4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.

5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.

Exclusion Criteria:

1. More than 2 acne nodules on the face at Baseline visit.

2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.

3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, 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 subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.

4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit

5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial.

6. Use of hormonal contraceptives solely for control of acne.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Investigational site	Birmingham	Alabama	United States
2	Galderma Investigationnal Site	Mobile	Alabama	United States
3	Galderma investigational Site	Hot Springs	Arkansas	United States
4	Galderma Investigational Site	Los Angeles	California	United States
5	Galderma Investigational Site	Sacramento	California	United States
6	Galderma Investigational Site	Santa Monica	California	United States
7	Galderma Investigational Site	Miami	Florida	United States
8	Galderma Investigational Site	Miramar	Florida	United States
9	Galderma Investiogational Site	Newnan	Georgia	United States
10	Galderma Investigational Site	Snellville	Georgia	United States
11	Galderma Investigational Site	Chicago	Illinois	United States
12	Galderma Investigational Site	Detroit	Michigan	United States
13	Galderma Investigational Site	Albuquerque	New Mexico	United States
14	Galderma Investigational Site	New York	New York	United States
15	Galderma Investigational Site	Stony Brook	New York	United States
16	Galderma Investigational Site	Raleigh	North Carolina	United States
17	Galderma Investigational Site	Beachwood	Ohio	United States
18	Galderma investigational Site	Hershey	Pennsylvania	United States
19	Galderma Investigational Site	Greenville	South Carolina	United States
20	Galderma Investigational Site	Goodlettsville	Tennessee	United States
21	Galderma Investigational Site	Knoxville	Tennessee	United States
22	Galderma Investigational Site	Arlington	Texas	United States
23	Galderma Investigational Site	San Antonio	Texas	United States
24	Galderma Investigational Site	Salt Lake City	Utah	United States
25	Galderma Investigational Site	Spokane	Washington	United States
26	Galderma Investigational Site	Barrie		Canada
27	Galderma Investigational Site	Markham		Canada
28	Galderma Investiogational Site	Montreal		Canada
29	Galderma Investigational Site	Peterborough		Canada
30	Galderma Investigational site	Surrey		Canada
31	Galderma Investigational Site	Waterloo		Canada

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01880320
• Other Study ID Numbers: RD.06.SPR.18240
• First Posted: Jun 18, 2013
• Last Update Posted: Jun 28, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle
Arm/Group Description	Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle
Period Title: Overall Study
STARTED	217	217	69
COMPLETED	197	192	61
NOT COMPLETED	20	25	8

Baseline Characteristics

Arm/Group Title	CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle	Total
Arm/Group Description	Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle	Total of all reporting groups
Overall Participants	217	217	69	503
Age (Count of Participants)
<=18 years	124 57.1%	136 62.7%	43 62.3%	303 60.2%
Between 18 and 65 years	93 42.9%	81 37.3%	26 37.7%	200 39.8%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.1 (7.59)	19.4 (6.75)	18.5 (5.72)	19.6 (7.01)
Sex: Female, Male (Count of Participants)
Female	113 52.1%	114 52.5%	36 52.2%	263 52.3%
Male	104 47.9%	103 47.5%	33 47.8%	240 47.7%
Region of Enrollment (participants) [Number]
Canada	17 7.8%	16 7.4%	5 7.2%	38 7.6%
United States	200 92.2%	201 92.6%	64 92.8%	465 92.4%
Baseline Investigator Global Assessment (IGA) (participants) [Number]
Baseline IGA = Moderate (3)	111 51.2%	105 48.4%	35 50.7%	251 49.9%
Baseline IGA = Severe (4)	106 48.8%	112 51.6%	34 49.3%	252 50.1%

Outcome Measures

1. Primary Outcome

Title	Success Rate
Description	Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.

Arm/Group Title	CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle
Arm/Group Description	Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle
Measure Participants	217	217	69
All subjects (MI: Multiple Imputation)	33.7 15.5%	27.3 12.6%	11.0 15.9%
Baseline IGA=Severe (4) (MI: Multiple Imputation)	31.9 14.7%	20.5 9.4%	11.8 17.1%

2. Primary Outcome

Title	Changes From Baseline in Inflammatory Lesion Counts
Time Frame	Baseline - Week12

Outcome Measure Data

Analysis Population Description

ITT Population, Multiple imputation

Arm/Group Title	CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle
Arm/Group Description	Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle
Measure Participants	217	217	69
All Subjects	-27.04 (0.846)	-26.72 (0.822)	-14.40 (1.460)
Baseline IGA = Severe (4)	-35.17 (1.407)	-31.92 (1.320)	-15.46 (2.297)

3. Primary Outcome

Title	Changes From Baseline in Non-Inflammatory Lesion Counts
Time Frame	Baseline - Week 12

Outcome Measure Data

Analysis Population Description

ITT Population, Multiple Imputation

Arm/Group Title	CD0271 0.3% /CD1579 2.5% Gel	CD0271 0.1% / CD1579 2.5%	Topical Gel Vehicle
Arm/Group Description	Active arm CD0271 0.3% / CD1579 2.5%	Comparator arm CD0271 0.1% / CD1579 2.5%	Placebo arm Topical Gel Vehicle
Measure Participants	217	217	69
All Subjects	-40.18 (1.332)	-39.00 (1.277)	-18.47 (2.270)
Baseline IGA = Severe (4)	-45.61 (2.058)	-43.10 (1.847)	-17.25 (3.337)

Adverse Events

Arm/Group Title	CD0271 0.3% /CD1579 2.5% Gel		CD0271 0.1% / CD1579 2.5%		Topical Gel Vehicle
Arm/Group Description	Active arm CD0271 0.3% / CD1579 2.5%		Comparator arm CD0271 0.1% / CD1579 2.5%		Placebo arm Topical Gel Vehicle
All Cause Mortality
	CD0271 0.3% /CD1579 2.5% Gel		CD0271 0.1% / CD1579 2.5%		Topical Gel Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CD0271 0.3% /CD1579 2.5% Gel		CD0271 0.1% / CD1579 2.5%		Topical Gel Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/217 (0%)		1/217 (0.5%)		0/69 (0%)
Psychiatric disorders
Generalized Anxiety Disorder	0/217 (0%)	0	1/217 (0.5%)	1	0/69 (0%)	0
Other (Not Including Serious) Adverse Events
	CD0271 0.3% /CD1579 2.5% Gel		CD0271 0.1% / CD1579 2.5%		Topical Gel Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/217 (15.7%)		23/217 (10.6%)		13/69 (18.8%)
Ear and labyrinth disorders
Motion sickness	0/217 (0%)		0/217 (0%)		1/69 (1.4%)
General disorders
Fatigue	0/217 (0%)		1/217 (0.5%)		1/69 (1.4%)
Pyrexia	0/217 (0%)		0/217 (0%)		1/69 (1.4%)
Infections and infestations
Nasopharyngitis	14/217 (6.5%)		11/217 (5.1%)		1/69 (1.4%)
Upper respiratory tract infection	1/217 (0.5%)		5/217 (2.3%)		4/69 (5.8%)
Infleunza	2/217 (0.9%)		2/217 (0.9%)		1/69 (1.4%)
Gastroenteritis	3/217 (1.4%)		1/217 (0.5%)		0/69 (0%)
Ear infection	0/217 (0%)		0/217 (0%)		1/69 (1.4%)
Pharyngitis	0/217 (0%)		0/217 (0%)		1/69 (1.4%)
Metabolism and nutrition disorders
Hypokalemia	0/217 (0%)		0/217 (0%)		1/69 (1.4%)
Nervous system disorders
Headache	3/217 (1.4%)		2/217 (0.9%)		1/69 (1.4%)
Dizziness	0/217 (0%)		0/217 (0%)		1/69 (1.4%)
Rhinitis seasonal	0/217 (0%)		0/217 (0%)		1/69 (1.4%)
Respiratory, thoracic and mediastinal disorders
Cough	1/217 (0.5%)		1/217 (0.5%)		1/69 (1.4%)
Skin and subcutaneous tissue disorders
Skin irritation	9/217 (4.1%)		1/217 (0.5%)		0/69 (0%)
Dermatitis allergic	1/217 (0.5%)		3/217 (1.4%)		0/69 (0%)
Eczema	3/217 (1.4%)		0/217 (0%)		0/69 (0%)
Rash	1/217 (0.5%)		0/217 (0%)		1/69 (1.4%)
Urticaria	1/217 (0.5%)		0/217 (0%)		1/69 (1.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.