CompletedPhase 3

Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

United States463 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Change in Inflammatory Lesion Count From Baseline to Week 12

Timeframe: 12 weeks

Percentage of Participants Who Achieved 2 Grade IGA Reduction.

Timeframe: 12 weeks

Trial details

NCT IDNCT02547441

SponsorMaruho Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07-05

Results submitted2022-06-13

View on ClinicalTrials.gov More Rosacea trials