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NCT02066545 Clinical Trial

Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:
A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02066545
Other study ID # CLS001-CO-PR-003
Secondary ID
Status Completed
Phase Phase 2
First received February 18, 2014
Last updated September 1, 2015
Start date April 2014

Study information
Verified date September 2015
Source Cutanea Life Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris

Recruitment information / eligibility
Status Completed
Enrollment 327
Est. completion date
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.

- Subjects with =20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.

- An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)

Exclusion Criteria:

- Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)

- Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)

- Subjects with more than 2 facial nodulocystic lesions

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CLS001 Topical Gel

• CLS001 Topical Gel Vehicle

Locations
Country Name City State
United States Academic Dermatology Associates Albuquerque New Mexico
United States Premier Research Austin Texas
United States Skin Care Research, Inc. Boca Raton Florida
United States J & S Studies, Inc. College Station Texas
United States Encino Research Center Encino California
United States Hamzavi Dermatology Fort Gratiot Michigan
United States Minnesota Clinical Study Center Fridley Minnesota
United States Dermatology Consulting Services High Point North Carolina
United States Tennessee Clinical Research Center Nashville Tennessee
United States Manhattan Dermatology & Cosmetic Center New York New York
United States MedaPhase, Inc. Newnan Georgia
United States Belleair Research Center Pinellas Park Florida
United States Wake Research Associates Raleigh North Carolina
United States Progressive Clinical Research, PA San Antonio Texas
United States Skin Surgery Medical Group, Inc. San Diego California
United States Clinical Science Institute Santa Monica California
United States Premier Clinical Research Spokane Washington
United States Derm Research Center of New York, Inc. Stony Brook New York
United States Moore Clinical Research, Inc. Tampa Florida
United States Kenneth R. Beer, MD, PA West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Cutanea Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in inflammatory lesion count from Baseline 6, 9 and 12 weeks No
Secondary Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions 1, 3, 6, 9 and 12 weeks No
Secondary Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions 1, 3, 6, 9 and 12 weeks No
Secondary Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit 1, 3, 6, 9, and 12 weeks No
Secondary Percentage of subjects with a 2 grade reduction in the IGA at each visit 1, 3, 6, 9, and 12 weeks No
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