Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

• Sponsor: Almirall, S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01628549
• Collaborator: Allergan (Industry)
• Enrollment: 285
• Locations: 38
• Arms: 4
• Actual Duration (Months): 7.1
• Patients Per Site: 7.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: 50 mg P005672-HCl; Drug: Placebo; Drug: 100 mg P005672-HCl	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 285 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411
• Actual Study Start Date: Jun 30, 2012
• Actual Primary Completion Date: Nov 16, 2012
• Actual Study Completion Date: Jan 31, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: P005672-HCl approximately 0.75 mg/kg/day One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks	Drug: 50 mg P005672-HCl; P005672-HCl administered as an oral capsule(s) once daily; Other Names: WC3035, Sarecycline ; Drug: Placebo; Dose-matched Placebo capsule administered as an oral capsule(s) once daily; Other Names: Inactive
Experimental: P005672-HCl approximately 1.5 mg/kg/day Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks	Drug: 50 mg P005672-HCl; P005672-HCl administered as an oral capsule(s) once daily; Other Names: WC3035, Sarecycline
Experimental: P005672-HCl approximately 3.0 mg/kg/day Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks	Drug: 100 mg P005672-HCl; P005672-HCl administered as an oral capsule(s) once daily; Other Names: WC3035, Sarecycline
Placebo Comparator: Placebo Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks	Drug: Placebo; Dose-matched Placebo capsule administered as an oral capsule(s) once daily; Other Names: Inactive

Outcome Measures

Primary Outcome Measures

1. The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit [Baseline (Week 0) to Final Visit (Up to Week 12)]

2. The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit [Final Visit (Up to Week 12)]

   The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.

Secondary Outcome Measures

1. The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit [Baseline (Week 0) up to Week 12]

2. The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit [Baseline (Week 0) up to Week 12]

3. The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit [Baseline (Week 0) up to Week 12]

4. The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit [Baseline (Week 0) up to Week 12]

5. The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 [Baseline to Final Visit (Up to Week 12)]

   The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• if women of child-bearing potential, have a negative urine pregnancy test

• Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study

• Male or female, 12-45 years of age with body weight between 52 and 88 kg

• Diagnosis of acne vulgaris with:

20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)

• No more than 2 nodules on the face

• Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)

Exclusion Criteria:

• Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible:

Within 1 week prior to randomization:

• Medicated facial cleansers

• Topical acne treatments (other than those listed below)

Within 4 weeks prior to randomization:

• Topical retinoids

• Topical anti-inflammatories and corticosteroids

• Systemic antibiotics

• Systemic acne treatments

Within 12 weeks prior to randomization:

• Systemic retinoids

• Systemic corticosteroids

• Pseudomembranous colitis or antibiotic-associated colitis

• Hepatitis, liver damage or renal impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warner Chilcott Investigational Site	Mobile	Alabama	United States	36608
2	Warner Chilcott Investigational Site	Tucson	Arizona	United States	85710
3	Warner Chilcott Investigational Site	Hot Springs	Arkansas	United States	71913
4	Warner Chilcott Investigational Site	Los Angeles	California	United States	90045
5	Warner Chilcott Investigational Site	San Diego	California	United States	92123
6	Warner Chilcott Investigational Site	Santa Monica	California	United States	90404
7	Warner Chilcott Investigational Site	Clearwater	Florida	United States	33761
8	Warner Chilcott Investigational Site	Coral Gables	Florida	United States	33134
9	Warner Chilcott Investigational Site	Gainesville	Florida	United States	32605
10	Warner Chilcott Investigational Site	Miami	Florida	United States	33175
11	Warner Chilcott Investigational Site	Miramar	Florida	United States	33027
12	Warner Chilcott Investigational Site	Pinellas Park	Florida	United States	33781
13	Warner Chilcott Investigational Site	Arlington Heights	Illinois	United States	60005
14	Warner Chilcott Investigational Site	Chicago	Illinois	United States	60611
15	Warner Chilcott Investigational Site	Granger	Indiana	United States	46530
16	Warner Chilcott Investigational Site	Indianapolis	Indiana	United States	46256
17	Warner Chilcott Investigational Site	Louisville	Kentucky	United States	40202
18	Warner Chilcott Investigational Site	Boston	Massachusetts	United States	02135
19	Warner Chilcott Investigational Site	Fridley	Minnesota	United States	44532
20	Warner Chilcott Investigational Site	Saint Louis	Missouri	United States	63117
21	Warner Chilcott Investigational Site	Berlin	New Jersey	United States	08009
22	Warner Chilcott Investigational Site	Albuquerque	New Mexico	United States	87106
23	Warner Chilcott Investigational Site	Rochester	New York	United States	14609
24	Warner Chilcott Investigational Site	Rochester	New York	United States	14623
25	Warner Chilcott Investigational Site	Charlotte	North Carolina	United States	28209
26	Warner Chilcott Investigational Site	Salisbury	North Carolina	United States	28144
27	Warner Chilcott Investigational Site	Wilmington	North Carolina	United States	28401
28	Warner Chilcott Investigational Site	Cincinnati	Ohio	United States	45249
29	Warner Chilcott Investigational Site	Portland	Oregon	United States	97210
30	Warner Chilcott Investigational Site	Philadelphia	Pennsylvania	United States	19103
31	Warner Chilcott Investigational Site	Greer	South Carolina	United States	29650
32	Warner Chilcott Investigational Site	Arlington	Texas	United States	76011
33	Warner Chilcott Investigational Site	Austin	Texas	United States	78759
34	Warner Chilcott Investigational Site	Houston	Texas	United States	77065
35	Warner Chilcott Investigational Site	Plano	Texas	United States	75093
36	Warner Chilcott Investigational Site	San Antonio	Texas	United States	78229
37	Warner Chilcott Investigational Site	Sandy	Utah	United States	84070
38	Warner Chilcott Investigational Site	Lynchburg	Virginia	United States	24501

Sponsors and Collaborators

• Almirall, S.A.
• Allergan

Investigators

• Study Director: Herman Ellman, MD, Warner Chilcott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Almirall, S.A.
• ClinicalTrials.gov Identifier: NCT01628549
• Other Study ID Numbers: PR-10411
• First Posted: Jun 26, 2012
• Last Update Posted: Feb 1, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Almirall, S.A.: acne
• Additional relevant MeSH terms: Acne Vulgaris; Sarecycline

Study Results

Participant Flow

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day
Period Title: Overall Study
STARTED	73	76	70	66
COMPLETED	64	64	60	57
NOT COMPLETED	9	12	10	9

Baseline Characteristics

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day	Total
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day	Total of all reporting groups
Overall Participants	73	76	70	66	285
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	20.8 (6.99)	19.7 (5.92)	19.9 (7.04)	20.3 (7.11)	20.2 (6.74)
Sex/Gender, Customized (Count of Participants)
Male	25 34.2%	29 38.2%	30 42.9%	29 43.9%	113 39.6%
Female	48 65.8%	47 61.8%	40 57.1%	37 56.1%	172 60.4%
Race/Ethnicity, Customized (Number) [Number]
Hispanic or Latino	19 26%	21 27.6%	16 22.9%	19 28.8%	75 26.3%
Not Hispanic or Latino	54 74%	55 72.4%	54 77.1%	47 71.2%	210 73.7%
Race/Ethnicity, Customized (Number) [Number]
American Indian or Alaska Native	1 1.4%	0 0%	0 0%	1 1.5%	2 0.7%
Asian	4 5.5%	4 5.3%	3 4.3%	1 1.5%	12 4.2%
Black or African American	17 23.3%	18 23.7%	21 30%	13 19.7%	69 24.2%
Native Hawaiian or Other Pacific islander	0 0%	0 0%	0 0%	0 0%	0 0%
White	54 74%	55 72.4%	46 65.7%	52 78.8%	207 72.6%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	165.80 (10.436)	167.49 (9.047)	167.23 (7.380)	167.33 (9.764)	166.96 (9.206)
Weight at Baseline (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	68.47 (10.306)	66.37 (8.749)	69.69 (11.861)	67.31 (9.486)	67.94 (10.173)

Outcome Measures

1. Primary Outcome

Title	The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Time Frame	Baseline (Week 0) to Final Visit (Up to Week 12)

Outcome Measure Data

Analysis Population Description

Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population.

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day
Measure Participants	72	76	70	66
Mean (Standard Deviation) [Number of Inflammatory Lesions]	12.8 (14.18)	14.4 (13.01)	17.6 (16.65)	17.1 (11.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, P005672-HCl Approximately 0.75 mg/kg/Day
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4344
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Means
	Estimated Value	1.53
	Confidence Interval	(2-Sided) 95%; -2.32 to 5.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, P005672-HCl Approximately 1.5 mg/kg/Day
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0266
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Means
	Estimated Value	4.46
	Confidence Interval	(2-Sided) 95%; 0.52 to 8.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, P005672-HCl Approximately 3.0 mg/kg/Day
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0317
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in Least Squares Means
	Estimated Value	4.37
	Confidence Interval	(2-Sided) 95%; 0.39 to 8.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
Description	The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Time Frame	Final Visit (Up to Week 12)

Outcome Measure Data

Analysis Population Description

Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day
Measure Participants	72	76	70	66
Success	8 11%	11 14.5%	17 24.3%	10 15.2%
Failure	64 87.7%	65 85.5%	53 75.7%	56 84.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, P005672-HCl Approximately 0.75 mg/kg/Day
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3300
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference vs placebo in success rate
	Estimated Value	3.4
	Confidence Interval	(2-Sided) 95%; -7.82 to 14.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, P005672-HCl Approximately 1.5 mg/kg/Day
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0159
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference vs placebo in success rate
	Estimated Value	13.2
	Confidence Interval	(2-Sided) 95%; 0.54 to 25.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, P005672-HCl Approximately 3.0 mg/kg/Day
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4834
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Difference vs placebo in success rate
	Estimated Value	4.1
	Confidence Interval	(2-Sided) 95%; -7.44 to 15.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
Time Frame	Baseline (Week 0) up to Week 12

Outcome Measure Data

Analysis Population Description

Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day
Measure Participants	72	76	70	66
Change from Baseline at Week 1	5.8 (9.07)	5.4 (9.28)	5.4 (8.44)	5.9 (8.33)
Change from Baseline at Week 2	8.4 (10.13)	8.5 (10.02)	8.2 (14.45)	9.7 (11.30)
Change from Baseline at Week 4	10.9 (10.04)	9.3 (13.84)	11.7 (15.36)	12.8 (9.96)
Change from Baseline at Week 8	12.6 (12.57)	13.1 (11.89)	15.0 (16.66)	14.3 (12.90)
Change from Baseline at Week 12	12.8 (14.18)	14.3 (13.00)	17.6 (16.65)	17.1 (11.69)
Change from Baseline at Final Visit(Up to Week 12)	12.8 (14.18)	14.4 (13.01)	17.6 (16.65)	17.1 (11.69)

4. Secondary Outcome

Title	The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time Frame	Baseline (Week 0) up to Week 12

Outcome Measure Data

Analysis Population Description

Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day
Measure Participants	72	76	70	66
Change from Baseline at Week 1	5.4 (12.99)	3.8 (14.28)	4.3 (14.10)	5.1 (13.83)
Change from Baseline at Week 2	10.6 (16.02)	9.4 (13.58)	7.8 (16.92)	7.9 (14.24)
Change from Baseline at Week 4	13.0 (24.17)	10.0 (17.25)	9.9 (20.58)	12.7 (15.24)
Change from Baseline at Week 8	16.9 (22.52)	14.3 (21.44)	14.0 (22.22)	15.2 (19.04)
Change from Baseline at Week 12	17.8 (21.63)	17.9 (19.85)	19.1 (22.33)	17.0 (21.56)
Change from Baseline at Final Visit(Up to Week 12)	17.8 (21.63)	17.9 (19.83)	19.1 (22.33)	17.0 (21.56)

5. Secondary Outcome

Title	The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time Frame	Baseline (Week 0) up to Week 12

Outcome Measure Data

Analysis Population Description

Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day
Measure Participants	72	76	70	66
Change from Baseline at Week 1	19.3 (27.82)	17.2 (28.43)	17.8 (26.39)	19.4 (26.17)
Change from Baseline at Week 2	25.6 (29.02)	26.4 (32.60)	25.8 (36.16)	30.6 (35.88)
Change from Baseline at Week 4	34.1 (28.84)	29.3 (38.90)	34.1 (35.27)	40.0 (31.83)
Change from Baseline at Week 8	37.9 (35.60)	39.8 (34.47)	44.3 (37.99)	44.5 (37.62)
Change from Baseline at Week 12	39.1 (43.00)	43.3 (39.70)	53.6 (37.65)	53.5 (35.18)
Change from Baseline at Final Visit(Up to Week 12)	39.1 (43.00)	43.5 (39.72)	53.6 (37.65)	53.5 (35.18)

6. Secondary Outcome

Title	The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time Frame	Baseline (Week 0) up to Week 12

Outcome Measure Data

Analysis Population Description

Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day
Measure Participants	72	76	70	66
Change from Baseline at Week 1	9.7 (24.07)	7.7 (26.87)	8.3 (25.20)	10.6 (25.63)
Change from Baseline at Week 2	19.0 (28.36)	16.7 (24.99)	14.6 (30.57)	16.0 (30.37)
Change from Baseline at Week 4	25.0 (37.78)	18.3 (33.17)	19.2 (35.60)	25.7 (29.27)
Change from Baseline at Week 8	30.5 (40.69)	26.1 (38.84)	27.5 (38.54)	30.4 (38.45)
Change from Baseline at Week 12	35.3 (35.32)	34.3 (36.40)	37.2 (38.44)	32.8 (42.59)
Change from Baseline at Final Visit(Up to Week 12)	35.3 (35.32)	34.1 (36.28)	37.2 (38.44)	32.8 (42.59)

7. Secondary Outcome

Title	The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
Description	The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Time Frame	Baseline to Final Visit (Up to Week 12)

Outcome Measure Data

Analysis Population Description

Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population

Arm/Group Title	Placebo	P005672-HCl Approximately 0.75 mg/kg/Day	P005672-HCl Approximately 1.5 mg/kg/Day	P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day	One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day	Two P005672-HCl 50 mg capsules, taken orally each day	Two P005672-HCl 100 mg capsules, taken orally each day
Measure Participants	72	76	70	66
Success	0 0%	3 3.9%	0 0%	1 1.5%
Failure	72 98.6%	73 96.1%	70 100%	65 98.5%
Success	2 2.7%	3 3.9%	2 2.9%	2 3%
Failure	70 95.9%	73 96.1%	68 97.1%	64 97%
Success	1 1.4%	2 2.6%	0 0%	4 6.1%
Failure	71 97.3%	74 97.4%	70 100%	62 93.9%
Success	6 8.2%	6 7.9%	8 11.4%	11 16.7%
Failure	66 90.4%	70 92.1%	62 88.6%	55 83.3%
Success	8 11%	11 14.5%	17 24.3%	10 15.2%
Failure	64 87.7%	65 85.5%	53 75.7%	56 84.8%
Success	8 11%	11 14.5%	17 24.3%	10 15.2%
Failure	64 87.7%	65 85.5%	53 75.7%	56 84.8%

Adverse Events

Time Frame	From Screening (up to week -12) to Week 12 plus 30 days.
Arm/Group Title	Placebo		P005672-HCl Approximately 0.75 mg/kg/Day		P005672-HCl Approximately 1.5 mg/kg/Day		P005672-HCl Approximately 3.0 mg/kg/Day
Arm/Group Description	Two placebo capsules matching P005672-HCl, taken orally each day		One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day		Two P005672-HCl 50 mg capsules, taken orally each day		Two P005672-HCl 100 mg capsules, taken orally each day
All Cause Mortality
	Placebo		P005672-HCl Approximately 0.75 mg/kg/Day		P005672-HCl Approximately 1.5 mg/kg/Day		P005672-HCl Approximately 3.0 mg/kg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		P005672-HCl Approximately 0.75 mg/kg/Day		P005672-HCl Approximately 1.5 mg/kg/Day		P005672-HCl Approximately 3.0 mg/kg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/76 (0%)		0/70 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		P005672-HCl Approximately 0.75 mg/kg/Day		P005672-HCl Approximately 1.5 mg/kg/Day		P005672-HCl Approximately 3.0 mg/kg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/73 (17.8%)		15/76 (19.7%)		8/70 (11.4%)		7/66 (10.6%)
Gastrointestinal disorders
Nausea	4/73 (5.5%)		6/76 (7.9%)		1/70 (1.4%)		2/66 (3%)
Infections and infestations
Nasopharyngitis	5/73 (6.8%)		4/76 (5.3%)		2/70 (2.9%)		2/66 (3%)
Nervous system disorders
Headache	8/73 (11%)		5/76 (6.6%)		5/70 (7.1%)		4/66 (6.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The data obtained in this study are the property of the Sponsor, any manuscript or other presentation of data must first be reviewed by the Sponsor before its submission.