Phase 2
N=741
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT03170388 ↗Enrolled (actual)
741
Serious AEs
0.5%
Results posted
Nov 2021
Primary outcome: Primary: Inflammatory Lesion Counts — -29.9; -26.7; -24.8; -26.8 lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IDP-126 Gel (Drug); IDP-126 Component A (Drug); IDP-126 Component B (Drug); IDP-126 Component C (Drug); IDP-126 Vehicle Gel (Drug)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammatory Lesion Counts |
-29.9; -26.7; -24.8; -26.8; -19.6 | — |
| PRIMARY Non-inflammatory Lesion Counts |
-35.5; -29.9; -27.8; -30.0; -21.8 | — |
| PRIMARY Percentage of Participants With Success on the Evaluator's Global Severity Score |
52.5; 27.8; 30.5; 30.3; 8.1 | — |
| SECONDARY Inflammatory Lesion Count Changes at Week 2, 4, and 8 |
-14.0; -11.8; -13.8; -13.4; -9.2; -21.0 | — |
| SECONDARY Non-inflammatory Lesion Count Changes at Week 2, 4, and 8 |
-12.9; -11.0; -11.2; -11.3; -9.2; -21.4 | — |
| SECONDARY Inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 |
-35.89; -30.27; -35.10; -35.23; -24.18; -54.42 | — |
| SECONDARY Non-inflammatory Lesion Count Percentage Changes at Week 2, 4, and 8 |
-27.07; -23.39; -23.72; -24.91; -19.68; -43.17 | — |
| SECONDARY Percentage of Participants With Success on the Evaluator's Global Severity Score at Weeks 2, 4, and 8 |
1.49; 1.35; 0.71; 2.68; 0.00; 8.17 | — |
| SECONDARY Percentage of Participants With Two Grade Success on the Evaluator's Global Severity Score - at Weeks 2, 4, and 8 |
2.95; 2.78; 1.45; 5.44; 1.36; 11.46 | — |
Summary
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Eligibility Criteria
Inclusion Criteria
- Male or female at least 9 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 20, but no more than 100.
- Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
- Subjects with 2 or fewer facial nodules
Exclusion Criteria
- Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- 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 a facial beard or mustache that could interfere with the study assessments.
- Subjects with more than 2 facial nodules.
- Evidence or history of cosmetic-related acne.
Data sourced from ClinicalTrials.gov (NCT03170388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.