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A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02815280
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.

Tracking Information
First Submitted Date  ICMJE May 24, 2016
First Posted Date  ICMJE June 28, 2016
Last Update Posted Date November 5, 2018
Actual Study Start Date  ICMJE May 2016
Actual Primary Completion Date October 13, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Severity of acne vulgaris assessed by Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ]
    To evaluate the success rate in the IGA (severity at 12 weeks = "Clear" or "Almost Clear") of topical FMX-101, 4% compared to vehicle
  • Number of inflammatory lesions assessed by direct count of facial lesions [ Time Frame: 12 weeks ]
    To evaluate the mean change in absolute inflammatory lesion count of topical FMX- 101, 4% compared to vehicle
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02815280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Official Title  ICMJE A Randomized, Double-Blind Study to Compare the Efficacy, Safety and Long-Term Safety of Topical Administration of FMX-101 for 1 Year in the Treatment of Moderate-to-Severe Acne Vulgaris, Study FX2014-05
Brief Summary This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.
Detailed Description This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: FMX-101, 4% minocycline foam
    FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
  • Drug: Vehicle Foam
    Vehicle foam applied topically once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: FMX-101, 4% minocycline foam
    FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
    Intervention: Drug: FMX-101, 4% minocycline foam
  • Placebo Comparator: Vehicle Foam
    Vehicle foam applied topically once daily for 12 weeks
    Intervention: Drug: Vehicle Foam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2016)
450
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 13, 2017
Actual Primary Completion Date October 13, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has facial acne vulgaris with:

    • 20 to 50 inflammatory lesions (papules, pustules, and nodules)
    • 25 to 100 noninflammatory lesions (open and closed comedones)
    • No more than 2 nodules on the face
    • IGA score of moderate (3) to severe (4)
  • Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study

Exclusion Criteria:

  • Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations
  • Sunburn on the face
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Dominican Republic,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02815280
Other Study ID Numbers  ICMJE FX2014-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Foamix Ltd.
Study Sponsor  ICMJE Foamix Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Foamix Ltd.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP