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CompletedNCT02066545Updated Sep 17, 2015

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

A Phase 2 interventional study of CLS001 Topical Gel and CLS001 Topical Gel Vehicle in Acne Vulgaris, sponsored by Maruho Co., Ltd.. Completed at 20 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2015-09-17.

Sponsored by Maruho Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
327
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.

This study's enrollment of 327 is above the median of 69 across 647 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Maruho Co., Ltd. is the lead sponsor of 27 studies on the registry; none are open to participants now.

Browse Maruho Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
327 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Change in inflammatory lesion count from Baseline

    Time frame: 6, 9 and 12 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Percentage of subjects with a 2 grade reduction in the IGA at each visit

    Time frame: 1, 3, 6, 9, and 12 weeks

07

Study locations

20 sites
  • Encino Research Center
    Encino, California 91436, United States
  • Skin Surgery Medical Group, Inc.
    San Diego, California 92117, United States
  • Clinical Science Institute
    Santa Monica, California 90404, United States
  • Skin Care Research, Inc.
    Boca Raton, Florida 33486, United States
  • Belleair Research Center
    Pinellas Park, Florida 33781, United States
  • Moore Clinical Research, Inc.
    Tampa, Florida 33609, United States
  • Kenneth R. Beer, MD, PA
    West Palm Beach, Florida 33401, United States
  • MedaPhase, Inc.
    Newnan, Georgia 30263, United States
  • Hamzavi Dermatology
    Fort Gratiot, Michigan 48059, United States
  • Minnesota Clinical Study Center
    Fridley, Minnesota 55432, United States
  • Academic Dermatology Associates
    Albuquerque, New Mexico 87106, United States
  • Manhattan Dermatology & Cosmetic Center
    New York, New York 10017, United States
  • Derm Research Center of New York, Inc.
    Stony Brook, New York 11790, United States
  • Dermatology Consulting Services
    High Point, North Carolina 27262, United States
  • Wake Research Associates
    Raleigh, North Carolina 27612, United States
  • Tennessee Clinical Research Center
    Nashville, Tennessee 37215, United States
  • Premier Research
    Austin, Texas 78705, United States
  • J & S Studies, Inc.
    College Station, Texas 77845, United States
  • Progressive Clinical Research, PA
    San Antonio, Texas 78229, United States
  • Premier Clinical Research
    Spokane, Washington 99204, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2014 and a primary completion of Nov 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2014
First posted
Feb 19, 2014
Start
Apr 2014
Primary completionActual
Nov 2014
Results delay requested
Aug 13, 2015
Last update
Sep 17, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02066545
Lead sponsor
Maruho Co., Ltd.
Responsible party
Sponsor
First posted
Feb 19, 2014
Start date
Apr 2014
Primary completion
Nov 2014
Last update
Sep 17, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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