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

Information source: Foamix Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Topical Minocycline Foam FXFM244 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Foamix Ltd.

Official(s) and/or principal investigator(s):
Joseph Shiri, Prof., Principal Investigator, Affiliation: Clalit Health Services
Eli Sprecher, MD, Principal Investigator, Affiliation: Sourasky medical center
Avner Shemer, Prof., Principal Investigator, Affiliation: Lev Yasmin clinic, Netanya, Israel

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Decrease in lesions count

Investigator global assessment

Secondary outcome:

% change in lesions count

Global assessment of improvement by photographs

Subject-reported outcome assessment

Subjects safety

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.

Eligibility

Minimum age: 12 Years. Maximum age: 25 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Lev Yasmin clinic, Netanya, Israel

Sourasky medical center, Tel-Aviv, Israel

Tel-Nordau Clalit health services, Tel-Aviv, Israel

Additional Information

Starting date: January 2012
Last updated: August 14, 2013

Page last updated: August 23, 2015

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