Phase 3
N=820
Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Acne
Bottom Line
View on ClinicalTrials.gov: NCT02932306 ↗Enrolled (actual)
820
Serious AEs
0.9%
Results posted
Jan 2020
Primary outcome: Primary: Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 — -17.8; -10.6 lesion count — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IDP-121 Lotion (Drug); IDP-121 Vehicle Lotion (Drug)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12 |
-17.8; -10.6 | <0.001 sig |
| PRIMARY Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12 |
-13.1; -10.2 | <0.001 sig |
| PRIMARY Percentage of Participants With Treatment Success at Week 12 |
16.5; 6.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Noninflammatory Lesion Count to Week 12 |
-47.5; -27.3 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Count to Week 12 |
-50.9; -40.4 | — |
Summary
The objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of IDP-121 Lotion compared with its vehicle (IDP-121 Vehicle Lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an Evaluator's Global Severity Score [EGSS] of 3 [moderate] or 4 [severe]).
Eligibility Criteria
Key Inclusion Criteria
- Male or female at least 9 years of age and older.
- Written and verbal informed consent must be obtained. Participants 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 participant reaches age of consent during the study they should be re-consented at the next study visit).
- Participant must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the screening and baseline visit
Key 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.
- 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.
- Participants with a facial beard or mustache that could interfere with the study assessments.
Data sourced from ClinicalTrials.gov (NCT02932306). 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.