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 |
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.
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
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.
We found this trial at
89
sites
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