Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients

NCT ID: NCT01134991

Last Updated: 2015-08-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30

Brief Summary

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.

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Topical Minocycline Foam FXFM244 Placebo

Minocycline Foam FXFM244 Placebo

Group Type: PLACEBO_COMPARATOR

Topical Minocycline Foam FXFM244

Intervention Type: DRUG

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

Topical Minocycline Foam FXFM244, 1%

Minocycline Foam FXFM244, 1%

Group Type: EXPERIMENTAL

Topical Minocycline Foam FXFM244

Intervention Type: DRUG

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

Topical Minocycline Foam FXFM244, 4%

Minocycline Foam FXFM244, 4%

Group Type: EXPERIMENTAL

Topical Minocycline Foam FXFM244

Intervention Type: DRUG

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

Interventions

Topical Minocycline Foam FXFM244

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

0041-10LND /FX2010-02

Identifier Type: -

Identifier Source: org_study_id