A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea

Vyne Therapeutics

Status and phase: Completed; Phase 3

Conditions: Facial Papulopustular Rosacea

Treatments: Drug: FMX103 minocycline foam 1.5%; Drug: Vehicle foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT04608500

FX2016-12

Details and patient eligibility

About

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.

Full description

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 participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:

• FMX103 minocycline foam 1.5%
• Vehicle foam

Participants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment [IGA] score) will be performed at Weeks 4, 8, and 12 during the study.

Note: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately.

Enrollment: 771 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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771 participants in 2 patient groups, including a placebo group

FMX103 1.5%

Experimental group

Description:

Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.

Treatment:

Drug: FMX103 minocycline foam 1.5%

Vehicle foam

Placebo Comparator group

Description:

Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.

Treatment:

Drug: Vehicle foam