NCT02601963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

October 19, 2015

Last Update Submit

February 14, 2017

Conditions

RosaceaPapulopustular Rosacea

Outcome Measures

Primary Outcomes (1)

  • the absolute change in inflammatory lesion count at Week 12 compared to Baseline.

    Baseline to Week 12

Secondary Outcomes (3)

  • The dichotomized Investigator's Global Assessment (IGA) score at Week 12 compared to Baseline

    Baseline to Week 12

  • Percent change in inflammatory lesion count at Week 12 compared to Baseline

    Baseline to Week 12

  • The dichotomized modified Investigator's Global Assessment (mIGA) score at Week 12 compared to Baseline.

    Baseline to Week 12

Study Arms (3)

FMX-103 1.5%

EXPERIMENTAL

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.

Drug: FMX-103 1.5%

FMX-103 3%

EXPERIMENTAL

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.

Drug: FMX-103 3%

Vehicle foam (0%)

PLACEBO COMPARATOR

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.

Drug: Vehicle foam (0%)

Interventions

FMX-103 1.5%DRUG

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

Also known as: Minocycline foam 1.5%
FMX-103 1.5%
FMX-103 3%DRUG

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

Also known as: Minocycline foam 3%
FMX-103 3%
Vehicle foam (0%)DRUG

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

Also known as: Placebo
Vehicle foam (0%)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil.
  • Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period.
  • Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema.
  • 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).
  • 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.
  • Bacterial folliculitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Berlin, 10783, Germany

Location

Unknown Facility

Berlin, 13055, Germany

Location

Unknown Facility

Berlin, 13086, Germany

Location

Unknown Facility

Berlin, 13507, Germany

Location

Unknown Facility

Blaubeuren Abbey, 89143, Germany

Location

Unknown Facility

Bochum, 44803, Germany

Location

Unknown Facility

Buxtehude, 21614, Germany

Location

Unknown Facility

Darmstadt, 64283, Germany

Location

Unknown Facility

Dülmen, 48249, Germany

Location

Unknown Facility

Düsseldorf, 40212, Germany

Location

Unknown Facility

Friedrichshafen, 88045, Germany

Location

Unknown Facility

Kiel, 24105, Germany

Location

Unknown Facility

Mahlow, 15831, Germany

Location

Unknown Facility

Mainz, 55131, Germany

Location

Unknown Facility

Osnabrück, 49078, Germany

Location

Unknown Facility

Schweinfurt, 97421, Germany

Location

Unknown Facility

Selters, 56242, Germany

Location

Unknown Facility

Stuttgart, 70178, Germany

Location

Unknown Facility

Stuttgart, 70499, Germany

Location

Unknown Facility

Ulm, 89081, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29396702DERIVED

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ulrich Mrowietz, MD

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

November 11, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 15, 2017

Record last verified: 2017-02

Locations

DE(20)