Acne Vulgaris
Conditions
Brief summary
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.
Detailed description
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score \[EGSS\] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.
Interventions
DRUGIDP-126 Gel
Gel applied to face once daily in the evening.
Gel applied to face once daily in the evening.
Gel applied to face once daily in the evening.
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female at least 12 years of age and older. * Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit). * Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit. * Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100. * Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150. * Subjects with 2 or fewer facial nodules.
Exclusion criteria
* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema. * Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * Subjects with more than 2 facial nodules. * Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study. * Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study. * Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area. * Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area. * Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications. * Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline to Week 12 in Lesion Counts. | Baseline to Week 12 | Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit. |
| Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. | Baseline to Week 12 | The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. |
Countries
Belgium, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IDP-126 Gel IDP-126 Gel: Gel applied to face once daily in the evening. | 230 |
| IDP-126 Vehicle Gel IDP-126 Vehicle Gel: Gel applied to face once daily in the evening. | 228 |
| Epiduo® Forte Gel Epiduo® Forte Gel: Gel applied to face once daily in the evening. | 226 |
| Total | 684 |
Baseline characteristics
| Characteristic | IDP-126 Gel | IDP-126 Vehicle Gel | Epiduo® Forte Gel | Total |
|---|---|---|---|---|
| Age, Continuous | 17.5 years | 17 years | 18 years | 17 years |
| Baseline Evaluator's Global Severity Score Moderate | 201 Participants | 204 Participants | 198 Participants | 603 Participants |
| Baseline Evaluator's Global Severity Score Severe | 29 Participants | 24 Participants | 28 Participants | 81 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 27 Participants | 19 Participants | 62 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 28 Participants | 26 Participants | 78 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 4 Participants | 11 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) White | 179 Participants | 160 Participants | 165 Participants | 504 Participants |
| Sex: Female, Male Female | 140 Participants | 131 Participants | 135 Participants | 406 Participants |
| Sex: Female, Male Male | 90 Participants | 97 Participants | 91 Participants | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 230 | 0 / 228 | 0 / 226 |
| other Total, other adverse events | 23 / 230 | 0 / 228 | 16 / 226 |
| serious Total, serious adverse events | 1 / 230 | 0 / 228 | 0 / 226 |
Outcome results
Primary
Absolute Change From Baseline to Week 12 in Lesion Counts.
Inflammatory and non-inflammatory lesion counts were collected starting from the Baseline Visit.
Time frame: Baseline to Week 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| IDP-126 Gel | Absolute Change From Baseline to Week 12 in Lesion Counts. | -29.9 lesion counts | Standard Deviation 11.43 |
| IDP-126 Vehicle Gel | Absolute Change From Baseline to Week 12 in Lesion Counts. | -19.7 lesion counts | Standard Deviation 13.11 |
| Epiduo® Forte Gel | Absolute Change From Baseline to Week 12 in Lesion Counts. | -27.9 lesion counts | Standard Deviation 12.16 |
Primary
Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score.
The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.
Time frame: Baseline to Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDP-126 Gel | Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. | 118 participants |
| IDP-126 Vehicle Gel | Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. | 41 participants |
| Epiduo® Forte Gel | Percentage of Subjects Who Achieve at Least a Two-grade Reduction From Baseline and Are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. | 74 participants |