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

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.

Study Overview

• Status: Terminated
• Conditions: Rosacea
• Intervention / Treatment: Drug: Topical Minocycline Foam FXFM244

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Patient is male or female over 18 years of age.
3. No known medical conditions that, in the Investigator's opinion could interfere with study participation
4. Patient is willing and able to comply with all requirement of the protocol
5. Patient is willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

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

4. 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)
5. Use of artificial sun bath or having a sun holiday during the last 2 weeks
6. Alcohol or drug abuse, according to assessment by the investigator
7. Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication
8. Use of another investigational drug within 30 days prior to entry into this study
9. Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Topical Minocycline Foam FXFM244 Placebo; Minocycline Foam FXFM244 Placebo	Drug: Topical Minocycline Foam FXFM244; FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks
Experimental: Topical Minocycline Foam FXFM244, 1%; Minocycline Foam FXFM244, 1%	Drug: Topical Minocycline Foam FXFM244; FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks
Experimental: Topical Minocycline Foam FXFM244, 4%; Minocycline Foam FXFM244, 4%	Drug: Topical Minocycline Foam FXFM244; FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in signs and symptoms of rosacea	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The severity of the overall rosacea condition will be measured at baseline and at all follow-up visits. The severity will be assessed and graded based on the scales for erythema, telangiectases and number of papulopustular lesions	0, 3, 6, 9 and 12 weeks

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): March 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 25, 2015
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: rosacea; phase II; topical; minocycline; foam
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: 0041-10LND /FX2010-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No