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

NCT01134991 | Terminated Phase 2

• 1 other identifier: 0041-10LND /FX2010-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Keywords

rosacea; topical; minocycline; foam; phase II

Outcome Measures

Primary Outcomes (1)

• Improvement in signs and symptoms of rosacea

  12 weeks

Secondary Outcomes (1)

• 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

Study Arms (3)

Topical Minocycline Foam FXFM244 Placebo

PLACEBO COMPARATOR

Minocycline Foam FXFM244 Placebo

Drug: Topical Minocycline Foam FXFM244

Topical Minocycline Foam FXFM244, 1%

EXPERIMENTAL

Minocycline Foam FXFM244, 1%

Drug: Topical Minocycline Foam FXFM244

Topical Minocycline Foam FXFM244, 4%

EXPERIMENTAL

Minocycline Foam FXFM244, 4%

Drug: Topical Minocycline Foam FXFM244

Interventions

Topical Minocycline Foam FXFM244 DRUG

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

Topical Minocycline Foam FXFM244 Placebo; Topical Minocycline Foam FXFM244, 1%; Topical Minocycline Foam FXFM244, 4%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Rosacea; cyclopia sequence

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 2, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2014
• Last Updated: August 26, 2015

Record last verified: 2010-08

Locations

IL (1)