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

Primary Purpose

Rosacea

Status

Terminated

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Topical Minocycline Foam FXFM244

About this trial

This is an interventional treatment trial for Rosacea focused on measuring rosacea, topical, minocycline, foam, phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Topical Minocycline Foam FXFM244 Placebo

Topical Minocycline Foam FXFM244, 1%

Topical Minocycline Foam FXFM244, 4%

Arm Description

Minocycline Foam FXFM244 Placebo

Minocycline Foam FXFM244, 1%

Minocycline Foam FXFM244, 4%

Outcomes

Primary Outcome Measures

Improvement in signs and symptoms of rosacea

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

Full Information

NCT ID

NCT01134991

First Posted

May 26, 2010

Last Updated

August 25, 2015

Sponsor

Vyne Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01134991

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Terminated

Why Stopped

Difficulty in recruitment

Study Start Date

June 2010 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vyne Therapeutics Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

Keywords

rosacea, topical, minocycline, foam, phase II

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topical Minocycline Foam FXFM244 Placebo

Arm Type

Placebo Comparator

Arm Description

Minocycline Foam FXFM244 Placebo

Arm Title

Topical Minocycline Foam FXFM244, 1%

Arm Type

Experimental

Arm Description

Minocycline Foam FXFM244, 1%

Arm Title

Topical Minocycline Foam FXFM244, 4%

Arm Type

Experimental

Arm Description

Minocycline Foam FXFM244, 4%

Intervention Type

Drug

Intervention Name(s)

Topical Minocycline Foam FXFM244

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in signs and symptoms of rosacea

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Time Frame

0, 3, 6, 9 and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Facility Information:

Facility Name

Sourasky Medical Center

City

Tel-Aviv

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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