Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients
Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study, to Evaluate the Tolerability and Safety of FXFM244 Antibiotic Foam and to Monitor Its Clinical Effect in Moderate to Severe Rosacea Patients
  • Phase

    Phase 2
  • Study Type

  • Status

  • Intervention/Treatment

    minocycline ...
  • Study Participants

Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a syndrome of undetermined etiology characterized by both vascular and papulopustular components involving the face and occasionally the neck and upper trunk.

This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.
A Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study. The study will involve three treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% or Placebo, in a blinded fashion. Patients will be treated twice daily for 12 weeks. Following the screening period and baseline visit, study subjects will return at Weeks 3, 6, 9 and 12. A follow up visit will take place at week 16. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.
Study Started
Jun 30
Primary Completion
Mar 31
Last Update
Aug 26

Drug Topical Minocycline Foam FXFM244

FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks

Topical Minocycline Foam FXFM244 Placebo Placebo Comparator

Minocycline Foam FXFM244 Placebo

Topical Minocycline Foam FXFM244, 1% Experimental

Minocycline Foam FXFM244, 1%

Topical Minocycline Foam FXFM244, 4% Experimental

Minocycline Foam FXFM244, 4%


Inclusion Criteria:

Patients with clinical diagnosis of moderate to severe facial rosacea as determined by:

At least 8 but no more than 50 total papules and/or pustules (inflammatory lesions)
Presence of moderate to severe erythema
Presence of telangiectasia.
An Overall Rosacea Severity score ≥2.5
Patient is male or female over 18 years of age.
No known medical conditions that, in the Investigator's opinion could interfere with study participation
Patient is willing and able to comply with all requirement of the protocol
Patient is willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

Presence of skin diseases at or near the investigational area
Immunosuppressed state or other serious systemic disease
Signs and/or symptoms of systemic infection

Concomitant medication:

Use of oral and/or topical antibiotic treatment within 14 days prior to study entry.
Use of any topical anti-rosacea agent except antibiotics within 14 days prior to study entry.
Use of cyproterone acetate, CPA-containing contraceptives (e.g. Diane) or other corticosteroids (during the last 3 months);
Use of retinoids (during the last 4 weeks)
Use of artificial sun bath or having a sun holiday during the last 2 weeks
Alcohol or drug abuse, according to assessment by the investigator
Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication
Use of another investigational drug within 30 days prior to entry into this study
Pregnant or lactating women.
No Results Posted