Acne Vulgaris
Conditions
Keywords
acne, irritation, objective sensory methods
Brief summary
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.
Detailed description
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.
Interventions
DRUGbenzoyl peroxide wash
5% benzoyl peroxide wash
DRUGTretinoin gel
0.04% tretinoin gel
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and non-pregnant or non-nursing females, 12 years or older, with facial acne vulgaris; * Minimum of 20 but no more than 50 inflammatory lesions (papules and pustules); * Minimum of 30 but no more than 100 facial non-inflammatory lesions (open and closed comedones); * Must have at least a rating of grade 3 on the Investigator Global severity scale at baseline
Exclusion criteria
* Known sensitivity to any of the ingredients in the study medication; * Any nodulocystic acne lesions; * Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study; * Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study; * Topical use of retinoids within two weeks prior to study start and throughout the duration of the study; * Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study; * If subject is taking birth control pills, she must be stabilized for at least three months prior to study start; * History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication; * Any significant medical conditions that could confound the interpretation of the study; * Excessive facial hair that may interfere with evaluations; * No use of tanning booths, sun lamps, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Facial Acne Lesion Count | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Baseline to Week 12 | 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). |
| Measurement of Success | Baseline to Week 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Same Time of Day 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day | 123 |
| Different Times of Day 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening | 124 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Moved | 1 | 0 |
| Overall Study | Per IRB-Subject became vulnerable | 1 | 0 |
| Overall Study | Personal Reasons | 6 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Different Times of Day | Total | Same Time of Day |
|---|---|---|---|
| Age Continuous | 18.6 years STANDARD_DEVIATION 6.94 | 18.5 years STANDARD_DEVIATION 6.89 | 18.5 years STANDARD_DEVIATION 6.86 |
| Fitzpatrick Score I | 5 Participants | 13 Participants | 8 Participants |
| Fitzpatrick Score II | 29 Participants | 60 Participants | 31 Participants |
| Fitzpatrick Score III | 52 Participants | 96 Participants | 44 Participants |
| Fitzpatrick Score IV | 22 Participants | 46 Participants | 24 Participants |
| Fitzpatrick Score V | 12 Participants | 20 Participants | 8 Participants |
| Fitzpatrick Score VI | 4 Participants | 12 Participants | 8 Participants |
| Region of Enrollment United States | 124 participants | 247 participants | 123 participants |
| Sex: Female, Male Female | 66 Participants | 126 Participants | 60 Participants |
| Sex: Female, Male Male | 58 Participants | 121 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 123 | 0 / 124 |
| serious Total, serious adverse events | 3 / 123 | 0 / 124 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Same Time of Day | Change From Baseline in Total Facial Acne Lesion Count | 39.74 Lesions | Standard Error 1.64 |
| Different Times of Day | Change From Baseline in Total Facial Acne Lesion Count | 40.02 Lesions | Standard Error 1.62 |
Secondary
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
Population: Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Same Time of Day | Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Inflammatory Lesions | 14.6 Lesions | Standard Error 0.85 |
| Same Time of Day | Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Non-Inflammatory Lesions | 23.2 Lesions | Standard Error 1.17 |
| Same Time of Day | Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Total Lesions | 37.4 Lesions | Standard Error 1.7 |
| Different Times of Day | Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Inflammatory Lesions | 14.2 Lesions | Standard Error 0.84 |
| Different Times of Day | Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Non-Inflammatory Lesions | 23.7 Lesions | Standard Error 1.16 |
| Different Times of Day | Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Total Lesions | 38.1 Lesions | Standard Error 1.68 |
Secondary
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
Population: Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Same Time of Day | Measurement of Success | Clear / Almost Clear | 26 Participants |
| Same Time of Day | Measurement of Success | Improved Two Categories | 51 Participants |
| Different Times of Day | Measurement of Success | Clear / Almost Clear | 25 Participants |
| Different Times of Day | Measurement of Success | Improved Two Categories | 54 Participants |