Phase 3
Completed N=263
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Source: ClinicalTrials.gov NCT02576860 ↗Enrolled (actual)
263
Serious AEs
0.4%
Results posted
Jul 2022
Primary outcomePrimary: Efficacy Absolute Change in Inflammatory Lesion Count — -19.8; -20.9 Lesions — p=0.799
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Absolute Change in Inflammatory Lesion Count |
-19.8; -20.9 | 0.799 |
| PRIMARY Efficacy IGA: 2 Grade Reduction |
24.6; 25.6 | 0.858 |
| SECONDARY Efficacy The Absolute Change in Inflammatory Lesions |
-16.2; -19.8 | — |
| SECONDARY Efficacy The Absolute Change in Inflammatory Lesions |
-16.2; -19.8 | — |
| SECONDARY Efficacy IGA: 2 Point Reduction |
15.2; 15.9 | — |
| SECONDARY Efficacy IGA: 2 Point Reduction |
15.2; 15.9 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy, male and non-pregnant female subjects, 18 years of age or older.
- A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
- Subjects with the presence of telangiectasia at Baseline.
- Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
- Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.
Exclusion Criteria
- Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
- Subjects with nodular rosacea.
- Standard exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT02576860). 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.