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

This study has been terminated.
(Difficulty in recruitment)
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.
ClinicalTrials.gov Identifier:
NCT01134991
First received: May 26, 2010
Last updated: December 9, 2013
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Rosacea
Drug: Topical Minocycline Foam FXFM244
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Foamix Ltd.:

Primary Outcome Measures:
  • Improvement in signs and symptoms of rosacea [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 0, 3, 6, 9 and 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: June 2010
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134991

Locations
Israel
Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Foamix Ltd.
  More Information

No publications provided

Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT01134991     History of Changes
Other Study ID Numbers: 0041-10LND /FX2010-02
Study First Received: May 26, 2010
Last Updated: December 9, 2013
Health Authority: Israel: Institutional Review Board - Laniado Hospital

Keywords provided by Foamix Ltd.:
rosacea
topical
minocycline
foam
phase II

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014