A Phase 4 interventional study of benzoyl peroxide wash and Tretinoin gel in Acne Vulgaris, sponsored by Bausch Health Americas, Inc.. Completed at 12 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2012-02-15.
Sponsored by Bausch Health Americas, Inc. · Phase 4, Interventional, and Treatment
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.
730 studies on the registry are indexed under Acne Vulgaris; 85 are open to participants now.
This study's enrollment of 247 is above the median of 68 across 627 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
Drug: benzoyl peroxide wash · Drug: Tretinoin gel
5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
Drug: benzoyl peroxide wash · Drug: Tretinoin gel
5% benzoyl peroxide wash
Also known as: OXY Wash
0.04% tretinoin gel
Also known as: Retin-A Micro Pump
Change From Baseline in Total Facial Acne Lesion Count
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
Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals
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
Measurement of Success
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
| Milestone | Same Time of Day | Different Times of Day |
|---|---|---|
| Started | 123 | 124 |
| Completed | 110 | 112 |
| Not completed | 13 | 12 |
| Withdrew: Adverse event | 0 | 4 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Per irb-subject became vulnerable | 1 | 0 |
| Withdrew: Moved | 1 | 0 |
| Withdrew: Personal reasons | 6 | 1 |
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.
| Lesions | Same Time of Day | Different Times of Day |
|---|---|---|
| Change From Baseline in Total Facial Acne Lesion Count | 39.74 ± 1.64 | 40.02 ± 1.62 |
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).
| Lesions | Same Time of Day | Different Times of Day |
|---|---|---|
| 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 |
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.
| Participants | Same Time of Day | Different Times of Day |
|---|---|---|
| Clear / Almost Clear | 26 | 25 |
| Improved Two Categories | 51 | 54 |
Collected over 12 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Same Time of Day | — | 3/123 (2.4%) | 0/123 (0%) |
| Different Times of Day | — | 0/124 (0%) | 0/124 (0%) |
| Event | Same Time of Day | Different Times of Day |
|---|---|---|
| Cardiac ArrhythmiaCardiac disorders | 1/123 | 0/124 |
| Viral MyocarditisCardiac disorders | 1/123 | 0/124 |
| Ovarian CystReproductive system and breast disorders | 1/123 | 0/124 |
| Age Continuous(years) | Same Time of Day | Different Times of Day | Total |
|---|---|---|---|
| Mean | 18.5 ± 6.86 | 18.6 ± 6.94 | 18.5 ± 6.89 |
| Sex: Female, Male(Participants) | Same Time of Day | Different Times of Day | Total |
|---|---|---|---|
| Female | 60 | 66 | 126 |
| Male | 63 | 58 | 121 |
| Region of Enrollment(participants) | Same Time of Day | Different Times of Day | Total |
|---|---|---|---|
| United States | 123 | 124 | 247 |
| Fitzpatrick Score(Participants) | Same Time of Day | Different Times of Day | Total |
|---|---|---|---|
| I | 8 | 5 | 13 |
| II | 31 | 29 | 60 |
| III | 44 | 52 | 96 |
| IV | 24 | 22 | 46 |
| V | 8 | 12 | 20 |
| VI | 8 | 4 | 12 |
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.