Phase 1
Completed N=12
A Study Comparing Two Topicals in the Treatment of Acne Vulgaris
Source: ClinicalTrials.gov NCT03743038 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 — 0; 0; 3; 3 Participants
Summary
A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 |
0; 0; 3; 3; 5; 3 | — |
| PRIMARY Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6 |
3; 3 | — |
| PRIMARY Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count |
-7.5; -6.3 | — |
| PRIMARY Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count |
-37.7; -39.0 | — |
| PRIMARY Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count |
-7.0; -5.0 | — |
| PRIMARY Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count |
-33.2; -24.0 | — |
| PRIMARY Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 |
1.6; -2.5; 6.0; 5.2; 3.9; 1.9 | — |
| PRIMARY Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 |
2.8; -0.4; 1.3; -1.2; -0.7; -0.6 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
5; 0; 0; 0 | — |
| PRIMARY Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline |
9; 9; 1; 1; 11; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Has facial acne vulgaris with:
16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right and left side of the face should be similar IGA score of moderate (3) on both the right and left side of the face
Exclusion Criteria
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- More than two facial nodules/cysts
- Sunburn on the face
Data sourced from ClinicalTrials.gov (NCT03743038). 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.