Phase 3
Completed N=463
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Source: ClinicalTrials.gov NCT02547441 ↗Enrolled (actual)
463
Serious AEs
1.9%
Results posted
Aug 2022
Primary outcomePrimary: Change in Inflammatory Lesion Count From Baseline to Week 12 — -18.1; -13.5 Lesions — p=0.043
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 Change in Inflammatory Lesion Count From Baseline to Week 12 |
-18.1; -13.5 | 0.043 sig |
| PRIMARY Percentage of Participants Who Achieved 2 Grade IGA Reduction. |
26.3; 16.9 | 0.019 sig |
| SECONDARY Change in the Number of Inflammatory Lesions From Baseline at Week 9 |
-17.4; -15.2 | — |
| SECONDARY Change in the Number of Inflammatory Lesions From Baseline at Week 6 |
-13.5; -11.8 | — |
| SECONDARY Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9. |
18.4; 14.4 | — |
| SECONDARY Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6. |
13.8; 8.9 | — |
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 (NCT02547441). 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.