Acne Vulgaris
Conditions
Keywords
acne, irritation, objective sensory methods
Brief summary
A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.
Detailed description
Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled in this randomized, double blind, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will receive either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the 12-week treatment period. Subjects will be monitored for safety throughout the study and for signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at study completion, week 12. Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment of Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be taken at Baseline and weeks 2, 4, 8 and 12.
Interventions
DRUGRetin-A Micro 0.04% facial acne treatment
Retin-A Micro 0.04% facial acne treatment used once daily
DRUGVehicle control
Color-matched facial gel vehicle control used once daily
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Males and non-pregnant, non-nursing females, 9 to 11 years, with facial pediatric acne vulgaris * Minimum of 20 non-inflammatory lesions (open and closed comedones) * Minimum of 30 total facial lesions (sum of inflammatory and non-inflammatory) * Must have at least a rating of grade 3 on the Investigator Global Assessment Scale for acne severity (IGA #1) 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 topical 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 * Use of an experimental drug or device within 60 days prior to study start; * Use of hormonal therapy within 3 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 * History of/or current facial skin cancer * Inability to refrain from use of all facial products other than those supplied by the study, while participating in the study * No use of tanning booths, sun lamps, etc. * Subject is a family member of the employee or the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Non-inflammatory Lesion Count | Baseline to Week 12 | Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lesion Counts | Baseline to Week 12 | Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement. |
| Measurement of Success 1 | Week 12 | Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear. |
| Measurement of Success 2 | Week 12 | Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear. |
| Measurement of Success 3 | Week 12 | Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of Excellent or Good scores. |
| Global Assessment | Baseline to Week 12 | Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retin-A Micro Retin-A Micro 0.04% facial acne treatment used once daily | 55 |
| Vehicle Control Color matched facial gel vehicle control used once daily | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Retin-A Micro | Total | Vehicle Control |
|---|---|---|---|
| Age, Customized 10 Years | 21 participants | 38 participants | 17 participants |
| Age, Customized 11 Years | 29 participants | 63 participants | 34 participants |
| Age, Customized 9 years | 5 participants | 9 participants | 4 participants |
| Fitzpatrick Score I | 2 Participants | 3 Participants | 1 Participants |
| Fitzpatrick Score II | 17 Participants | 29 Participants | 12 Participants |
| Fitzpatrick Score III | 11 Participants | 27 Participants | 16 Participants |
| Fitzpatrick Score IV | 14 Participants | 29 Participants | 15 Participants |
| Fitzpatrick Score V | 8 Participants | 17 Participants | 9 Participants |
| Fitzpatrick Score VI | 3 Participants | 5 Participants | 2 Participants |
| Region of Enrollment United States | 55 participants | 110 participants | 55 participants |
| Sex: Female, Male Female | 44 Participants | 82 Participants | 38 Participants |
| Sex: Female, Male Male | 11 Participants | 28 Participants | 17 Participants |
| Subject Reached Puberty No | 38 Participants | 72 Participants | 34 Participants |
| Subject Reached Puberty Yes | 17 Participants | 38 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 55 | 7 / 55 |
| serious Total, serious adverse events | 0 / 55 | 1 / 55 |
Outcome results
Primary
Change From Baseline in Total Non-inflammatory Lesion Count
Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
Time frame: Baseline to Week 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Retin-A Micro | Change From Baseline in Total Non-inflammatory Lesion Count | -19.9 Lesions | Standard Error 4.13 |
| Vehicle Control | Change From Baseline in Total Non-inflammatory Lesion Count | -9.7 Lesions | Standard Error 4.42 |
Secondary
Change From Baseline in Lesion Counts
Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.
Time frame: Baseline to Week 12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Retin-A Micro | Change From Baseline in Lesion Counts | Papules | -0.62 Lesions | Standard Error 0.75 |
| Retin-A Micro | Change From Baseline in Lesion Counts | Open Comedones | -4.10 Lesions | Standard Error 1.77 |
| Retin-A Micro | Change From Baseline in Lesion Counts | Inflammatory | -0.63 Lesions | Standard Error 1.16 |
| Retin-A Micro | Change From Baseline in Lesion Counts | Closed Comedones | -15.16 Lesions | Standard Error 2.92 |
| Retin-A Micro | Change From Baseline in Lesion Counts | Comedones | -19.85 Lesions | Standard Error 4.13 |
| Retin-A Micro | Change From Baseline in Lesion Counts | Pustules | -0.17 Lesions | Standard Error 0.77 |
| Retin-A Micro | Change From Baseline in Lesion Counts | Total Lesions | -21.87 Lesions | Standard Error 4.64 |
| Vehicle Control | Change From Baseline in Lesion Counts | Pustules | 1.04 Lesions | Standard Error 0.81 |
| Vehicle Control | Change From Baseline in Lesion Counts | Comedones | -9.67 Lesions | Standard Error 4.42 |
| Vehicle Control | Change From Baseline in Lesion Counts | Inflammatory | 0.54 Lesions | Standard Error 1.23 |
| Vehicle Control | Change From Baseline in Lesion Counts | Total Lesions | -10.88 Lesions | Standard Error 4.97 |
| Vehicle Control | Change From Baseline in Lesion Counts | Open Comedones | -2.86 Lesions | Standard Error 1.87 |
| Vehicle Control | Change From Baseline in Lesion Counts | Closed Comedones | -6.09 Lesions | Standard Error 3.14 |
| Vehicle Control | Change From Baseline in Lesion Counts | Papules | -0.48 Lesions | Standard Error 0.79 |
Secondary
Global Assessment
Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.
Time frame: Baseline to Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retin-A Micro | Global Assessment | Good | 19 Participants |
| Retin-A Micro | Global Assessment | No Change | 5 Participants |
| Retin-A Micro | Global Assessment | Fair | 11 Participants |
| Retin-A Micro | Global Assessment | Worse | 0 Participants |
| Retin-A Micro | Global Assessment | Excellent | 12 Participants |
| Vehicle Control | Global Assessment | Worse | 0 Participants |
| Vehicle Control | Global Assessment | Excellent | 7 Participants |
| Vehicle Control | Global Assessment | Good | 20 Participants |
| Vehicle Control | Global Assessment | Fair | 9 Participants |
| Vehicle Control | Global Assessment | No Change | 18 Participants |
Secondary
Measurement of Success 1
Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.
Time frame: Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retin-A Micro | Measurement of Success 1 | Clear/Almost Clear | 11 Participants |
| Retin-A Micro | Measurement of Success 1 | At Least 2 Grades Improvement | 15 Participants |
| Vehicle Control | Measurement of Success 1 | Clear/Almost Clear | 11 Participants |
| Vehicle Control | Measurement of Success 1 | At Least 2 Grades Improvement | 12 Participants |
Secondary
Measurement of Success 2
Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.
Time frame: Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retin-A Micro | Measurement of Success 2 | At Least 2 Grades Improvement | 8 Participants |
| Retin-A Micro | Measurement of Success 2 | Clear/Almost Clear | 10 Participants |
| Vehicle Control | Measurement of Success 2 | Clear/Almost Clear | 10 Participants |
| Vehicle Control | Measurement of Success 2 | At Least 2 Grades Improvement | 8 Participants |
Secondary
Measurement of Success 3
Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of Excellent or Good scores.
Time frame: Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Retin-A Micro | Measurement of Success 3 | Success | 31 Participants |
| Retin-A Micro | Measurement of Success 3 | No Success | 16 Participants |
| Vehicle Control | Measurement of Success 3 | Success | 27 Participants |
| Vehicle Control | Measurement of Success 3 | No Success | 27 Participants |