Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris Patients

Pilot, Multicenter, 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 Acne Vulgaris Patients

The purpose of this study is to evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Topical Minocycline Foam FXFM244

Detailed Description

This is a phase IIa prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and efficacy of Minocycline Foam 1% and 4% for the treatment of Acne Vulgaris.

The study consists of a screening / baseline visit, a treatment period where patients will be treated topically on the facial skin areas affected by acne twice daily for 12 weeks, followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patients.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Netanya, Israel
    • Lev Yasmin Clinic
  • Tel-Aviv, Israel
    • Sourasky Medical Center
  • Tel-Aviv, Israel
    • Tel-Nordau Clalit health services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A clinical diagnosis of Acne Vulgaris with facial involvement.
• A minimum of 20 but not more than 50 inflammatory lesions on the face (papules and/ or pustules).
• A minimum of 25 but not more than 100 non-inflammatory lesions on the face (opened and/or closed comedones).
• No significant nodulocystic acne on the face (≤ 2 lesions).
• A score of >3 (Moderate) on the Investigator's Global Assessment Scale.
• Patient is male or female between the ages of 12 to 25.
• No known medical conditions that, in the Investigator's opinion could interfere with study participation.
• Patient is willing to refrain from use of all other topical acne medications or antibiotics during the study.
• Patient is willing to refrain from use of moisturizers, new brands of make-up, creams, lotions, powders or any topical product other than the assigned treatment to the treatment area.
• 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.
• If female of childbearing potential, willing to use an acceptable form of birth control during the study. Use of oral contraceptives must remain constant within 3 month prior to baseline and throughout the study.

Exclusion Criteria:

• Acne Conglobata, Acne Fulminas, secondary acne (chloracne, drug induced acne), or severe acne requiring systemic treatment.
• Presence of any facial skin condition that would interfere with the diagnosis or assessment of Acne Vulgaris (e.g. rosacea, dermatitis, psoriasis, squamos cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
• Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of Acne Vulgaris.
• Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication.
• Concomitant medication:
• Use within 6 month prior to baseline of topical retinoids, oral retinoids (Accutane®) or therapeutic Protocol No. FX2010-03 Foamix Ltd. Page 8 of 28 Confidential Ver: 02 Oct-31-2011 vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
• Use of systemic steroids, systemic antibiotics, systemic treatment for Acne Vulgaris, systemic antiinflammatory agents within 4 weeks prior to baseline.
• Use of topical steroids, α-hydroxy/glycolic acid, benzoyl peroxide, topical antibiotics, topical treatment for Acne Vulgaris, topical anti-inflammatory agents within 2 weeks prior to baseline.
• Use for less than 3 month prior to baseline of estrogens or change in oral contraceptives therapy within less than 3 month prior to baseline;
• Use on the face of: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids or X-ray therapy within 4 weeks prior to baseline..
• Alcohol or drug abuse, according to assessment by the investigator.
• Use of another investigational drug within 30 days prior to baseline.
• Pregnant or lactating women.
• Use of tanning booths, sunbathing, or excessive exposure to the sun should be prohibited during the study.
• Participation in clinical trial in the previous month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Minocycline Foam FXFM244 - 4%; Active ingredient: Minocycline Concentration: 4% Route: Topical Dosage schedule: Once daily, evening.	Drug: Topical Minocycline Foam FXFM244; Topically applied once a day.; Other Names: FXFM244 antibiotic foam
Experimental: Topical Minocycline Foam FXFM244 - 1%; Active ingredient: Minocycline Concentration: 1% Route: Topical Dosage schedule: Once daily, evening.	Drug: Topical Minocycline Foam FXFM244; Topically applied once a day.; Other Names: FXFM244 antibiotic foam
Placebo Comparator: Placebo foam; Active ingredient: None Route: Topical Dosage schedule: Once daily, evening	Drug: Topical Minocycline Foam FXFM244; Topically applied once a day.; Other Names: FXFM244 antibiotic foam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in lesions count	The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline	12 weeks
Investigator global assessment	Physician's Global Improvement Assessment	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% change in lesions count	The % change in lesions count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline	12 weeks
Global assessment of improvement by photographs	The photographs will assist in comparison of efficacy at subsequent visits compared to baseline	12 weeks
Subject-reported outcome assessment		12 weeks
Subjects safety	safety parameters will be assessed by; Physical examination; Vital signs (HR, BP, Body temperature); Adverse events recording; Clinical assessment of skin irritation	12 weeks

Collaborators and Investigators

• Sponsor: Vyne Therapeutics Inc.
• Investigators: Principal Investigator: Joseph Shiri, Prof., Clalit Health Services; Principal Investigator: Eli Sprecher, MD, Sourasky Medical Center; Principal Investigator: Avner Shemer, Prof., Lev Yasmin clinic, Netanya, Israel

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Estimate): August 15, 2013
• Last Update Submitted That Met QC Criteria: August 14, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Acne; Phase II; Topical; Acne Vulgaris; Minocycline; Foam
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: FX2010-03