NCT02066545

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

February 18, 2014

Last Update Submit

September 1, 2015

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Change in inflammatory lesion count from Baseline

    6, 9 and 12 weeks

Secondary Outcomes (4)

  • 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

Study Arms (4)

Vehicle Gel

PLACEBO COMPARATOR
Drug: CLS001 Topical Gel Vehicle

CLS001 topical gel 1%

EXPERIMENTAL

Topical application once daily

Drug: CLS001 Topical Gel

CLS001 topical gel 1.75%

EXPERIMENTAL

Topical application once daily

Drug: CLS001 Topical Gel

CLS001 topical gel 2.5%

EXPERIMENTAL

Topical application once daily

Drug: CLS001 Topical Gel

Interventions

CLS001 Topical GelDRUG
CLS001 topical gel 1%CLS001 topical gel 1.75%CLS001 topical gel 2.5%
CLS001 Topical Gel VehicleDRUG
Vehicle Gel

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Encino Research Center

Encino, California, 91436, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

Belleair Research Center

Pinellas Park, Florida, 33781, United States

Location

Moore Clinical Research, Inc.

Tampa, Florida, 33609, United States

Location

Kenneth R. Beer, MD, PA

West Palm Beach, Florida, 33401, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Manhattan Dermatology & Cosmetic Center

New York, New York, 10017, United States

Location

Derm Research Center of New York, Inc.

Stony Brook, New York, 11790, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Premier Research

Austin, Texas, 78705, United States

Location

J & S Studies, Inc.

College Station, Texas, 77845, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78229, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 19, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

US(20)