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A Study of a New Drug Treatment for Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01326780
Recruitment Status : Completed
First Posted : March 31, 2011
Results First Posted : December 11, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: 1.2% JNJ 10229570-AAA
Drug: 2.4% JNJ 10229570-AAA
Drug: 3.6% JNJ 10229570-AAA
Other: Vehicle control
Enrollment 431
Recruitment Details 18 investigational sites: First patient enrolled: 08 March 2011, Last patient completed: 02 March 2012
Pre-assignment Details 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
Hide 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
Arm/Group Title 0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream Total
Hide 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 Number of Baseline Participants 106 109 109 107 431
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 109 participants 109 participants 107 participants 431 participants
19.9  (7.6) 17.3  (4) 19.7  (7) 17.9  (5.5) 18.7  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 109 participants 109 participants 107 participants 431 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 106 participants 109 participants 109 participants 107 participants 431 participants
106
 100.0%
109
 100.0%
109
 100.0%
107
 100.0%
431
 100.0%
1.Primary Outcome
Title Change in Total Acne Lesion Counts
Hide Description Change in lesion counts between baseline and end of study
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream
Hide 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
Overall Number of Participants Analyzed 106 109 109 107
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Change in sum of open and closed comedones.
Time Frame Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream
Hide 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
Overall Number of Participants Analyzed 106 109 109 107
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Change in sum of papules and pustules
Time Frame Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream
Hide 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
Overall Number of Participants Analyzed 106 109 109 107
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)
Time Frame Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream
Hide 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
Overall Number of Participants Analyzed 106 109 109 107
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)
Time Frame Baseline through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream
Hide 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
Overall Number of Participants Analyzed 106 109 109 107
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)
Time Frame Baseline through Week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream
Hide 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
Overall Number of Participants Analyzed 106 109 109 107
Mean (Standard Deviation)
Unit of Measure: Percent change
-33.9  (32.7) -27.8  (35.1) -36.5  (36.5) -37.7  (29.9)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/106 (0.00%)   0/109 (0.00%)   0/109 (0.00%)   0/107 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
0% Facial Cream 1.2% Facial Cream 2.4% Facial Cream 3.6% Facial Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/106 (19.81%)   17/109 (15.60%)   14/109 (12.84%)   15/107 (14.02%) 
General disorders         
Application Site Pruritis * 1  2/106 (1.89%)  2/109 (1.83%)  3/109 (2.75%)  1/107 (0.93%) 
Infections and infestations         
Nasal Congestion * 1  2/106 (1.89%)  3/109 (2.75%)  0/109 (0.00%)  0/107 (0.00%) 
Injury, poisoning and procedural complications         
Influenza * 1  0/106 (0.00%)  1/109 (0.92%)  4/109 (3.67%)  0/107 (0.00%) 
Nervous system disorders         
Headache * 1  1/106 (0.94%)  2/109 (1.83%)  0/109 (0.00%)  4/107 (3.74%) 
Respiratory, thoracic and mediastinal disorders         
nasopharyngitis * 1  9/106 (8.49%)  7/109 (6.42%)  3/109 (2.75%)  7/107 (6.54%) 
Oropharyngeal Pain * 1  3/106 (2.83%)  0/109 (0.00%)  1/109 (0.92%)  3/107 (2.80%) 
Skin and subcutaneous tissue disorders         
Acne * 1  4/106 (3.77%)  2/109 (1.83%)  3/109 (2.75%)  0/107 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Johnson Varughese
Organization: Valeant
Phone: 908 927-1162
EMail: johnson.varughese@bauschhealth.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01326780    
Other Study ID Numbers: CA-P-8023
First Submitted: March 30, 2011
First Posted: March 31, 2011
Results First Submitted: May 22, 2017
Results First Posted: December 11, 2018
Last Update Posted: October 16, 2019