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

This study has been completed.
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc. Identifier:
First received: February 18, 2014
Last updated: September 1, 2015
Last verified: September 2015
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

Condition Intervention Phase
Acne Vulgaris
Drug: CLS001 Topical Gel
Drug: CLS001 Topical Gel Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Cutanea Life Sciences, Inc.:

Primary Outcome Measures:
  • Change in inflammatory lesion count from Baseline [ Time Frame: 6, 9 and 12 weeks ]

Secondary Outcome Measures:
  • Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions [ Time Frame: 1, 3, 6, 9 and 12 weeks ]
  • Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions [ Time Frame: 1, 3, 6, 9 and 12 weeks ]
  • Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit [ Time Frame: 1, 3, 6, 9, and 12 weeks ]
  • Percentage of subjects with a 2 grade reduction in the IGA at each visit [ Time Frame: 1, 3, 6, 9, and 12 weeks ]

Enrollment: 327
Study Start Date: April 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle Gel Drug: CLS001 Topical Gel Vehicle
Experimental: CLS001 topical gel 1%
Topical application once daily
Drug: CLS001 Topical Gel
Experimental: CLS001 topical gel 1.75%
Topical application once daily
Drug: CLS001 Topical Gel
Experimental: CLS001 topical gel 2.5%
Topical application once daily
Drug: CLS001 Topical Gel


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02066545

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Sponsors and Collaborators
Cutanea Life Sciences, Inc.
  More Information

Responsible Party: Cutanea Life Sciences, Inc. Identifier: NCT02066545     History of Changes
Other Study ID Numbers: CLS001-CO-PR-003
Study First Received: February 18, 2014
Last Updated: September 1, 2015

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases processed this record on April 28, 2017