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



Status:Completed
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2015
End Date:September 5, 2017

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A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period

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.


Inclusion Criteria:

1. Healthy, male and non-pregnant female subjects, 18 years of age or older.

2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at
Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.

3. Subjects with the presence of telangiectasia at Baseline.

4. Subjects with an erythema score of at least 2 on the Investigator Assessment of
Erythema scale at Baseline.

5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

2. Subjects with nodular rosacea.

3. Standard exclusion criteria.
We found this trial at
20
sites
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High Point, NC
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Arlington, TX
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Boynton Beach, FL
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Charleston, South Carolina 29412
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Charleston, SC
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Fort Smith, AR
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Fort Washington, PA
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Manhattan Beach, California 90266
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Miami, FL
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Omaha, NE
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Plainfield, IN
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Raleigh, NC
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Rogers, AR
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Verona, NJ
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Washington,
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Watertown, MA
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Winston-Salem, NC
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