A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
Condition: Facial Papulopustular Rosacea
MeSH terms: Rosacea; Facies
Intervention: FMX103 minocycline foam 1.5%; Vehicle foam
Intervention description: Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.; Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
Intervention MeSH terms: Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: This is a double-blind study, with limited access to the randomization code. The randomization code will be held in confidence until after the study database is locked and a memo documenting the database lock has been issued. Every effort will be made to retain the integrity of the blind. When issued to the sites, the study drug will be identical in appearance for all participants, regardless of treatment assignment.
Enrollment: 771.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Topical Minocycline Foam; 2-Arm study; Inflammatory lesion counts; Investigator's Global Assessment score

Summary:

      The primary objectives of this study 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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Moderate-to-severe rosacea (as per the IGA score) 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.