Status:
COMPLETED
Clinical Study to Evaluate Tolerability and Safety of ARK-E021 Foam and to Monitor Clinical Effect in Acne Vulgaris Patients
Lead Sponsor:
M. Arkin 1999 Ltd.
Collaborating Sponsors:
Vyne Therapeutics Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-40 years
Phase:
PHASE1
PHASE2
Brief 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 moderat...
Detailed Description
This is a phase I/II prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and preliminary effi...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01494285
Start Date
June 1 2012
End Date
October 1 2013
Last Update
December 3 2013
Active Locations (3)
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1
HaEmek Medical Center
Afula, Israel
2
Meir Medical Center
Kfar Saba, Israel
3
Souraski Medical Center
Tel Aviv, Israel