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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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by Foamix Ltd.
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.
ClinicalTrials.gov Identifier:
NCT02815280
First received: May 24, 2016
Last updated: June 23, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Acne Vulgaris Drug: FMX-101, 4% minocycline foam Drug: Vehicle Foam Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Foamix Ltd.:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 450
Study Start Date: May 2016
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%.
  Eligibility

Ages Eligible for Study:   9 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02815280

Contacts
Contact: TKL Research 201-587-0500

  Show 33 Study Locations
Sponsors and Collaborators
Foamix Ltd.
  More Information

Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT02815280     History of Changes
Other Study ID Numbers: FX2014-05
Study First Received: May 24, 2016
Last Updated: June 23, 2016
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

ClinicalTrials.gov processed this record on August 16, 2017