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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

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ClinicalTrials.gov Identifier: NCT02815280
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: FMX-101, 4% minocycline foam Drug: Vehicle Foam Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2016
Actual Primary Completion Date : October 13, 2017
Actual Study Completion Date : October 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
Drug: FMX-101, 4% minocycline foam
FMX-101, 4% minocycline foam applied topically once daily for 12 weeks

Placebo Comparator: Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks
Drug: Vehicle Foam
Vehicle foam applied topically once daily for 12 weeks




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815280


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Sponsors and Collaborators
Foamix Ltd.

Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT02815280     History of Changes
Other Study ID Numbers: FX2014-05
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Foamix Ltd.:
acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents