Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients
Information source: Foamix Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: Topical Minocycline Foam FXFM244 (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Foamix Ltd.
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Improvement in signs and symptoms of rosacea
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sourasky Medical Center, Tel-Aviv, Israel
Additional Information
Starting date: June 2010
Last updated: December 9, 2013
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