Clinical Study to Evaluate Tolerability and Safety of ARK-E021 Foam and to Monitor Clinical Effect in Acne Vulgaris Patients

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group, ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with mild to moderate acne vulgaris.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M. Arkin 1999 Ltd.
• Collaborators: Foamix Ltd.; Vyne Therapeutics Inc.

Criteria

Main Inclusion Criteria:

• Patient is male or female between the ages of 12 to 40.

• A clinical diagnosis of acne vulgaris with facial involvement.

• Minimum of 15 inflammatory lesions on the face (papules and/ or pustules)but not more than 40.

• Existence of non-inflammatory lesions on the face (opened and/or closed comedones).

• A score of ≥2 (moderate) on the investigator's global assessment scale.

• Use of non oral contraceptives in female of childbearing potential during the study.

• No known medical conditions that, in the Investigator's opinion could interfere with study participation.

• Patient is willing and able to comply with all the requirement of the study protocol.

• Patient is willing and able to give written informed consent prior to participation in the study.

Main Exclusion Criteria:

• Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne), or severe acne requiring systemic treatment.

• One or more active nodule/cyst acne on the face (inactive lesions allowed).

• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.

• Participation in another investigational drug trial within 30 days prior to study entry.

• Concomitant medication:

• Use of systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris, systemic anti-inflammatory agents within 4 weeks prior to baseline or during the study.

• Use of topical steroids, topical antibiotics, topical treatment for acne vulgaris, topical anti-inflammatory agents within 2 weeks prior to baseline or during the study.

• Treatment for acne with isotretinoin or isotretinoin derivatives within 12 months prior to study entry.