A Study of a New Drug Treatment for Acne

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01326780
• Collaborator: (none)
• Enrollment: 431
• Locations: 18
• Arms: 4
• Actual Duration (Months): 12
• Patients Per Site: 23.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: 1.2% JNJ 10229570-AAA; Drug: 2.4% JNJ 10229570-AAA; Drug: 3.6% JNJ 10229570-AAA; Other: Vehicle control	Phase 2

Detailed Description

Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.

Study Design

• Study Type: Interventional
• Actual Enrollment: 431 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
• Actual Study Start Date: Mar 31, 2011
• Actual Primary Completion Date: Mar 31, 2012
• Actual Study Completion Date: Mar 31, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1.2% Facial Cream 1.2% JNJ 10229570-AAA	Drug: 1.2% JNJ 10229570-AAA; 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks; Other Names: Not yet marketed
Experimental: 2.4% Facial Cream 2.4% JNJ 10229570-AAA	Drug: 2.4% JNJ 10229570-AAA; 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks; Other Names: Not yet marketed
Experimental: 3.6% Facial Cream 3.6% JNJ 10229570-AAA	Drug: 3.6% JNJ 10229570-AAA; 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks; Other Names: Not yet marketed
Placebo Comparator: 0% Facial Cream Vehicle control	Other: Vehicle control; Color matched cream vehicle, applied once daily to the face for 12 weeks; Other Names: Not marketed

Outcome Measures

Primary Outcome Measures

1. Change in Total Acne Lesion Counts [Baseline to Week 12]

   Change in lesion counts between baseline and end of study

Secondary Outcome Measures

1. Change From Baseline in the Non-inflammatory Acne Lesion Counts [Baseline through Week 12]

   Change in sum of open and closed comedones.

2. Change From Baseline in the Inflammatory Acne Lesion Counts [Baseline through Week 12]

   Change in sum of papules and pustules

3. Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts [Baseline through Week 12]

   Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)

4. Percent Change From Baseline in the Inflammatory Acne Lesion Counts [Baseline through Week 12]

   Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)

5. Percent Change From Baseline in Total Acne Lesion Counts [Baseline through Week 12.]

   Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 12 years of age or older, with moderate facial acne vulgaris as defined in the protocol

• If female of childbearing potential, must take a pregnancy test and have a negative result

• Females of childbearing potential must also agree to use an adequate method of birth control, which would include:

• systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study)

• Condom with spermicide

• IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods

Exclusion Criteria:

• Known sensitivity to any of the ingredients in the study medication

• More than 3 nodulocystic acne lesions

• Use of acne treatments, therapies or medications within protocol-specified timeframes

• Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety

• Excessive facial hair that may interfere with application of the medication and/or evaluations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92093
2	University Clinical Trials, Inc.	San Diego	California	United States	92123
3	Thomas J. Stephens & Associates, Inc.	Colorado Springs	Colorado	United States	80915
4	Horizons Clinical Research Ctr., LLC	Denver	Colorado	United States	80220
5	North Florida Dermatology	Jacksonville	Florida	United States	32204
6	Hilltop Research	Saint Petersburg	Florida	United States	33710
7	Gwinnett Clinical Research	Snellville	Georgia	United States	30078
8	Northwestern University	Chicago	Illinois	United States	60611
9	Dermatology Specialists Research, Inc	Louisville	Kentucky	United States	40202
10	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
11	TKL Research	Rochelle Park	New Jersey	United States	07662
12	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
13	Wake Research Associates	Raleigh	North Carolina	United States	27612
14	Hilltop Research	Miamiville	Ohio	United States	45147
15	Penn State Medical Center	Hershey	Pennsylvania	United States	17033
16	Yardley Dermatology Associates	Yardley	Pennsylvania	United States	19067
17	Research Across America	Dallas	Texas	United States	75234
18	Reliance Clinical Testing Services	Irving	Texas	United States	75062

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Johnson Varughese, Bausch Health Americas, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA's Drug Finder

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT01326780
• Other Study ID Numbers: CA-P-8023
• First Posted: Mar 31, 2011
• Last Update Posted: Oct 16, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Bausch Health Americas, Inc.: Acne; Irritation; Safety; Sebum
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Recruitment Details	18 investigational sites: First patient enrolled: 08 March 2011, Last patient completed: 02 March 2012
Pre-assignment Detail	male and female subjects with moderate facial acne vulgaris, who met the entry criteria, were randomized with equal allocation to either 1.2%, 2.4%, or 3.6% JNJ 10229570-AAA cream or color-matched vehicle

Arm/Group Title	0% Facial Cream	1.2% Facial Cream	2.4% Facial Cream	3.6% Facial Cream
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks	1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks	2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks	3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Period Title: Overall Study
STARTED	106	109	109	107
COMPLETED	93	100	103	94
NOT COMPLETED	13	9	6	13

Baseline Characteristics

Arm/Group Title	0% Facial Cream	1.2% Facial Cream	2.4% Facial Cream	3.6% Facial Cream	Total
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks	1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks	2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks	3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks	Total of all reporting groups
Overall Participants	106	109	109	107	431
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.9 (7.6)	17.3 (4)	19.7 (7)	17.9 (5.5)	18.7 (6.2)
Sex: Female, Male (Count of Participants)
Female	49 46.2%	45 41.3%	51 46.8%	53 49.5%	198 45.9%
Male	57 53.8%	64 58.7%	58 53.2%	54 50.5%	233 54.1%
Region of Enrollment (Count of Participants)
United States	106 100%	109 100%	109 100%	107 100%	431 100%

Outcome Measures

1. Primary Outcome

Title	Change in Total Acne Lesion Counts
Description	Change in lesion counts between baseline and end of study
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0% Facial Cream	1.2% Facial Cream	2.4% Facial Cream	3.6% Facial Cream
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks	1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks	2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks	3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Measure Participants	106	109	109	107
Mean (Standard Deviation) [Lesions]	-26.0 (27.43)	-25.2 (30.23)	-29.4 (30.30)	-33.1 (29.32)

2. Secondary Outcome

Title	Change From Baseline in the Non-inflammatory Acne Lesion Counts
Description	Change in sum of open and closed comedones.
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0% Facial Cream	1.2% Facial Cream	2.4% Facial Cream	3.6% Facial Cream
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks	1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks	2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks	3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Measure Participants	106	109	109	107
Mean (Standard Deviation) [Lesions]	-12.6 (20.3)	-12.0 (21.2)	-14.3 (20.9)	-15.3 (21.9)

3. Secondary Outcome

Title	Change From Baseline in the Inflammatory Acne Lesion Counts
Description	Change in sum of papules and pustules
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0% Facial Cream	1.2% Facial Cream	2.4% Facial Cream	3.6% Facial Cream
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks	1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks	2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks	3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Measure Participants	106	109	109	107
Mean (Standard Deviation) [Lesions]	-13.4 (13.4)	-13.2 (16.3)	-15.1 (14.1)	-18.1 (12.9)

4. Secondary Outcome

Title	Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
Description	Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0% Facial Cream	1.2% Facial Cream	2.4% Facial Cream	3.6% Facial Cream
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks	1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks	2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks	3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Measure Participants	106	109	109	107
Mean (Standard Deviation) [Percent change]	-28.6 (39.3)	-21.7 (43.1)	-31.2 (41.0)	-30.8 (37.6)

5. Secondary Outcome

Title	Percent Change From Baseline in the Inflammatory Acne Lesion Counts
Description	Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)
Time Frame	Baseline through Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0% Facial Cream	1.2% Facial Cream	2.4% Facial Cream	3.6% Facial Cream
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks	1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks	2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks	3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Measure Participants	106	109	109	107
Mean (Standard Deviation) [Percent change]	-39.6 (36.3)	-35.4 (45.3)	-44.7 (41.1)	-48.5 (31.9)

6. Secondary Outcome

Title	Percent Change From Baseline in Total Acne Lesion Counts
Description	Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)
Time Frame	Baseline through Week 12.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0% Facial Cream	1.2% Facial Cream	2.4% Facial Cream	3.6% Facial Cream
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks	1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks	2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks	3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Measure Participants	106	109	109	107
Mean (Standard Deviation) [Percent change]	-33.9 (32.7)	-27.8 (35.1)	-36.5 (36.5)	-37.7 (29.9)

Adverse Events

Time Frame	Through 12 weeks.
Adverse Event Reporting Description	Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
Arm/Group Title	0% Facial Cream		1.2% Facial Cream		2.4% Facial Cream		3.6% Facial Cream
Arm/Group Description	Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks		1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks		2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks		3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
All Cause Mortality
	0% Facial Cream		1.2% Facial Cream		2.4% Facial Cream		3.6% Facial Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	0% Facial Cream		1.2% Facial Cream		2.4% Facial Cream		3.6% Facial Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/106 (0%)		0/109 (0%)		0/109 (0%)		0/107 (0%)
Other (Not Including Serious) Adverse Events
	0% Facial Cream		1.2% Facial Cream		2.4% Facial Cream		3.6% Facial Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/106 (19.8%)		17/109 (15.6%)		14/109 (12.8%)		15/107 (14%)
General disorders
Application Site Pruritis	2/106 (1.9%)		2/109 (1.8%)		3/109 (2.8%)		1/107 (0.9%)
Infections and infestations
Nasal Congestion	2/106 (1.9%)		3/109 (2.8%)		0/109 (0%)		0/107 (0%)
Injury, poisoning and procedural complications
Influenza	0/106 (0%)		1/109 (0.9%)		4/109 (3.7%)		0/107 (0%)
Nervous system disorders
Headache	1/106 (0.9%)		2/109 (1.8%)		0/109 (0%)		4/107 (3.7%)
Respiratory, thoracic and mediastinal disorders
nasopharyngitis	9/106 (8.5%)		7/109 (6.4%)		3/109 (2.8%)		7/107 (6.5%)
Oropharyngeal Pain	3/106 (2.8%)		0/109 (0%)		1/109 (0.9%)		3/107 (2.8%)
Skin and subcutaneous tissue disorders
Acne	4/106 (3.8%)		2/109 (1.8%)		3/109 (2.8%)		0/107 (0%)

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.