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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Topical Minocycline Foam FXFM244


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne, Acne Vulgaris, Topical, Minocycline, Foam, Phase II