A Study of Different Use Regimens Using Two Acne Treatments

• ClinicalTrials.gov Identifier: NCT00907257
• Recruitment Status: Completed
• First Posted: May 22, 2009
• Results First Posted: January 21, 2011
• Last Update Posted: February 15, 2012
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris
• Interventions: Drug: benzoyl peroxide wash; Drug: Tretinoin gel
• Enrollment: 247

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Same Time of Day	Different Times of Day
Arm/Group Description	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Period Title: Overall Study
Started	123	124
Completed	110	112
Not Completed	13	12
Reason Not Completed
Adverse Event	0	4
Protocol Violation	1	2
Lost to Follow-up	3	3
Withdrawal by Subject	1	2
Per IRB-Subject became vulnerable	1	0
Moved	1	0
Personal Reasons	6	1

Baseline Characteristics

Arm/Group Title		Same Time of Day	Different Times of Day	Total
Arm/Group Description		5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening	Total of all reporting groups
Overall Number of Baseline Participants		123	124	247
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	123 participants	124 participants	247 participants
		18.5 (6.86)	18.6 (6.94)	18.5 (6.89)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	123 participants	124 participants	247 participants
	Female	60 48.8%	66 53.2%	126 51.0%
	Male	63 51.2%	58 46.8%	121 49.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	123 participants	124 participants	247 participants
		123	124	247
Fitzpatrick Score [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	123 participants	124 participants	247 participants
I		8	5	13
II		31	29	60
III		44	52	96
IV		24	22	46
V		8	12	20
VI		8	4	12
		[1] Measure Description: Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI).

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Total Facial Acne Lesion Count
Description	Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Per Protocol Population, which includes all Intention to Treat (ITT) subjects who completed the 12 weeks of treatment and evaluations with no major protocol deviations.

Arm/Group Title	Same Time of Day	Different Times of Day
Arm/Group Description:	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Overall Number of Participants Analyzed	109	112
Least Squares Mean (Standard Error); Unit of Measure: Lesions
	39.74 (1.64)	40.02 (1.62)

2. Secondary Outcome

Title	Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
Description	Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF).

Arm/Group Title	Same Time of Day	Different Times of Day
Arm/Group Description:	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Overall Number of Participants Analyzed	123	124
Least Squares Mean (Standard Error); Unit of Measure: Lesions
Inflammatory Lesions	14.6 (0.85)	14.2 (0.84)
Non-Inflammatory Lesions	23.2 (1.17)	23.7 (1.16)
Total Lesions	37.4 (1.70)	38.1 (1.68)

3. Secondary Outcome

Title	Measurement of Success
Description	Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows: 0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF)

Arm/Group Title	Same Time of Day	Different Times of Day
Arm/Group Description:	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Overall Number of Participants Analyzed	123	124
Measure Type: Number; Unit of Measure: Participants
Clear / Almost Clear	26	25
Improved Two Categories	51	54

Adverse Events

Time Frame	12 Weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Same Time of Day	Different Times of Day
Arm/Group Description	5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
All-Cause Mortality
	Same Time of Day	Different Times of Day
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Same Time of Day	Different Times of Day
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/123 (2.44%)	0/124 (0.00%)
Cardiac disorders
Cardiac Arrhythmia * 1	1/123 (0.81%)	0/124 (0.00%)
Viral Myocarditis * 1	1/123 (0.81%)	0/124 (0.00%)
Reproductive system and breast disorders
Ovarian Cyst * 1	1/123 (0.81%)	0/124 (0.00%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Same Time of Day	Different Times of Day
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/123 (0.00%)	0/124 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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

• Name/Title: David Lineberry
• Organization: Valeant Pharmaceuticals International, Inc
• Phone: 949-973-1153
• EMail: David.Lineberry@valeant.com

Publications of Results:

Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT00907257
• Other Study ID Numbers: CA-P-6270
• First Submitted: May 20, 2009
• First Posted: May 22, 2009
• Results First Submitted: December 22, 2010
• Results First Posted: January 21, 2011
• Last Update Posted: February 15, 2012