A Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea



Status:Completed
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:11/29/2018
Start Date:June 9, 2017
End Date:October 29, 2018

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A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-11 and 12)

The Primary Objectives of FX2016-11 and FX2016-12 are to determine the efficacy and safety of
FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of
rosacea.

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate
the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to
vehicle, in the treatment of subjects with moderate-to-severe facial papulopustular rosacea.
Qualified subjects will be randomized to receive 1 of the following 2 treatments:

- FMX103 minocycline foam 1.5%

- Vehicle foam

Inclusion Criteria:

1. Moderate-to-severe rosacea (as per the IGA score; Table 3) on the proposed facial
treatment area consisting of:

1. At least 15 and not more than 75 facial papules and pustules, excluding lesions
involving the eyes and scalp;

2. No more than 2 nodules on the face.

2. Presence of or history of erythema and/or flushing on the face.

Exclusion Criteria:

1. Presence of any skin condition and/or Excessive facial hair, on the face that would
interfere with the diagnosis or assessment of rosacea.

2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like
facial edema.

3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of
any other component of the formulation.

4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient
severity to require topical or systemic antibiotics.
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Webster, Texas 77598
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Alpharetta, Georgia 30022
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Ann Arbor, Michigan 48103
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Bay City, Michigan 48706
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Beverly, Massachusetts 01915
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Charleston, South Carolina 29407
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