Clinical trial NCT02601963: Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
Official title: A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Two Different Doses of a Topical Minocycline Foam Compared to Vehicle in the Treatment of Papulopustular Rosacea - Study FX2015-10
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Papulopustular Rosacea
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea.

The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.

Approximately 210 patients will participate in this study.


Eligibility criteria: Inclusion Criteria:

1. Participants age is 18 years or older.
2. Participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp.
3. Subject must have diagnosed rosacea for at least 6 months prior to screening.

Exclusion Criteria:

1. History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil.
2. Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period.
3. Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema.
4. Rosacea conglobata or fulminans, corticosteroid-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (e.g., known carcinoid syndrome).
5. Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical ophthalmic or systemic antibiotics, papulopustular rosacea that requires medically indicated systemic treatment.
6. Bacterial folliculitis.

Primary outcomes:
measure: the absolute change in inflammatory lesion count at Week 12 compared to Baseline.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline
timeFrame: Baseline to Week 12
measure: Percent change in inflammatory lesion count at Week 12 compared to Baseline
timeFrame: Baseline to Week 12
measure: The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Blaubeuren
country: Germany
city: Bochum
country: Germany
city: Buxtehude
country: Germany
city: Darmstadt
country: Germany
city: Dülmen
country: Germany
city: Düsseldorf
country: Germany
city: Friedrichshafen
country: Germany
city: Kiel
country: Germany
city: Mahlow
country: Germany
city: Mainz
country: Germany
city: Osnabrück
country: Germany
city: Schweinfurt
country: Germany
city: Selters
country: Germany
city: Stuttgart
country: Germany
city: Stuttgart
country: Germany
city: Ulm
country: Germany
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Ulrich Mrowietz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mrowietz U, Kedem TH, Keynan R, Eini M, Tamarkin D, Rom D, Shirvan M. A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea. Am J Clin Dermatol. 2018 Jun;19(3):427-436. doi: 10.1007/s40257-017-0339-0.