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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02066545

Enrollment

327

Registered

2014-02-19

Start date

2014-04-30

Completion date

Unknown

Last updated

2015-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief 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

Interventions

DRUGCLS001 Topical Gel

DRUGCLS001 Topical Gel Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in inflammatory lesion count from Baseline	6, 9 and 12 weeks

Secondary

Measure	Time frame
Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions	1, 3, 6, 9 and 12 weeks
Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions	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	1, 3, 6, 9, and 12 weeks
Percentage of subjects with a 2 grade reduction in the IGA at each visit	1, 3, 6, 9, and 12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026