Trial Outcomes & Findings for A Study of Different Use Regimens Using Two Acne Treatments (NCT NCT00907257)

Last Updated: 2012-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

247 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2012-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Same Time of Day 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	Different Times of Day 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Overall Study STARTED	123	124
Overall Study COMPLETED	110	112
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Same Time of Day 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	Different Times of Day 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Overall Study Adverse Event	0	4
Overall Study Protocol Violation	1	2
Overall Study Lost to Follow-up	3	3
Overall Study Withdrawal by Subject	1	2
Overall Study Per IRB-Subject became vulnerable	1	0
Overall Study Moved	1	0
Overall Study Personal Reasons	6	1

Baseline Characteristics

A Study of Different Use Regimens Using Two Acne Treatments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Same Time of Day n=123 Participants 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	Different Times of Day n=124 Participants 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening	Total n=247 Participants Total of all reporting groups
Age Continuous	18.5 years STANDARD_DEVIATION 6.86 • n=93 Participants	18.6 years STANDARD_DEVIATION 6.94 • n=4 Participants	18.5 years STANDARD_DEVIATION 6.89 • n=27 Participants
Sex: Female, Male Female	60 Participants n=93 Participants	66 Participants n=4 Participants	126 Participants n=27 Participants
Sex: Female, Male Male	63 Participants n=93 Participants	58 Participants n=4 Participants	121 Participants n=27 Participants
Region of Enrollment United States	123 participants n=93 Participants	124 participants n=4 Participants	247 participants n=27 Participants
Fitzpatrick Score I	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Fitzpatrick Score II	31 Participants n=93 Participants	29 Participants n=4 Participants	60 Participants n=27 Participants
Fitzpatrick Score III	44 Participants n=93 Participants	52 Participants n=4 Participants	96 Participants n=27 Participants
Fitzpatrick Score IV	24 Participants n=93 Participants	22 Participants n=4 Participants	46 Participants n=27 Participants
Fitzpatrick Score V	8 Participants n=93 Participants	12 Participants n=4 Participants	20 Participants n=27 Participants
Fitzpatrick Score VI	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Same Time of Day n=109 Participants 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	Different Times of Day n=112 Participants 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Change From Baseline in Total Facial Acne Lesion Count	39.74 Lesions Standard Error 1.64	40.02 Lesions Standard Error 1.62

SECONDARY outcome

Timeframe: Baseline to Week 12

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

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).

Outcome measures

Outcome measures
Measure	Same Time of Day n=123 Participants 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	Different Times of Day n=124 Participants 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals Inflammatory Lesions	14.6 Lesions Standard Error 0.85	14.2 Lesions Standard Error 0.84
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals Non-Inflammatory Lesions	23.2 Lesions Standard Error 1.17	23.7 Lesions Standard Error 1.16
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals Total Lesions	37.4 Lesions Standard Error 1.70	38.1 Lesions Standard Error 1.68

SECONDARY outcome

Timeframe: Baseline to Week 12

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

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.

Outcome measures

Outcome measures
Measure	Same Time of Day n=123 Participants 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	Different Times of Day n=124 Participants 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Measurement of Success Clear / Almost Clear	26 Participants	25 Participants
Measurement of Success Improved Two Categories	51 Participants	54 Participants

Adverse Events

Same Time of Day

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Different Times of Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Same Time of Day n=123 participants at risk 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day	Different Times of Day n=124 participants at risk 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Cardiac disorders Cardiac Arrhythmia	0.81% 1/123 • 12 Weeks	0.00% 0/124 • 12 Weeks
Cardiac disorders Viral Myocarditis	0.81% 1/123 • 12 Weeks	0.00% 0/124 • 12 Weeks
Reproductive system and breast disorders Ovarian Cyst	0.81% 1/123 • 12 Weeks	0.00% 0/124 • 12 Weeks

Other adverse events

Adverse event data not reported

Additional Information

David Lineberry

Valeant Pharmaceuticals International, Inc

Phone: 949-973-1153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60