Phase 3
Completed N=498
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
Source: ClinicalTrials.gov NCT01701024 ↗Enrolled (actual)
498
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Absolute Change in Inflammatory Lesion Count — 16.3; 8.2 Lesion count
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Inflammatory Lesion Count |
16.3; 8.2 | — |
| PRIMARY Absolute Change in Non-inflammatory Lesion Count |
19.2; 9.6 | — |
| PRIMARY Percent of Subjects Who Have a Least a 2 Grade Reduction |
35.2; 17 | — |
| PRIMARY Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear |
28.5; 14.5 | — |
Eligibility Criteria
Key Inclusion Criteria
- Male or female between the ages of 12 and 40 (inclusive)
- Written and verbal informed consent must be obtained.
- Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent
- Subject must have moderate to severe acne at the baseline visit
- Women of childbearing potential must be willing to practice effective contraception for the duration of the study
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
- Dermatological conditions on the face that could interfere with clinical evaluations
Data sourced from ClinicalTrials.gov (NCT01701024). 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.