Phase 3
Completed N=813
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
Source: ClinicalTrials.gov NCT03168321 ↗Enrolled (actual)
813
Serious AEs
0.8%
Results posted
Apr 2021
Primary outcomePrimary: Absolute Change in Mean Lesion Counts at Week 12 — -21.0; -16.4; -15.6; -12.4 lesion counts
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123 Vehicle Lotion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Mean Lesion Counts at Week 12 |
-21.0; -16.4; -15.6; -12.4 | — |
| PRIMARY Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) and Had an EGSS at Week 12 That Equated to "Clear" or "Almost Clear" |
25.5; 13.0 | — |
| SECONDARY Percentage Change in Mean Lesion Counts at Week 12 |
-51.36; 41.47; -55.52; -45.70 | — |
| SECONDARY Percentage of Subjects Who Had at Least a 2-grade Reduction From Baseline at Week 12 in the Evaluator's Global Severity Score (EGSS) |
28.3; 15.2 | — |
| SECONDARY Percentage Change in Mean Lesion Counts at Week 8 |
-43.08; -34.34; -45.30; -38.96 | — |
| SECONDARY Percentage Change in Mean Lesion Counts at Week 4 |
-29.43; -23.25; -27.27; -29.70 | — |
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 a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment at the baseline visit;
- Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50;
- Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100;
- Subjects with two or fewer 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 two (2) facial nodules;
- Evidence or history of cosmetic-related acne
Data sourced from ClinicalTrials.gov (NCT03168321). 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. Informational only — not medical advice.