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.
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 efficacy of ARK-E021 foam for treatment of acne vulgaris. It is anticipated that the study will be conducted at the listed Medical Centers as well as out-patient clinics at the community. Approximately 144 male and female subjects with mild to moderate facial acne vulgaris will be enrolled in this study. Following satisfaction of the entry criteria and screening procedures, subjects will be randomized to either 5% or 10% topical foam (ARK-E021) or placebo foam. Subjects will apply the study medication once daily on the face at bedtime 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 patient. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at baseline and at weeks 3, 6, 9, 12 and 16.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
157
Topically applied once daily at bedtime
Topically applied once daily at bedtime
Topically applied once daily at bedtime
HaEmek Medical Center
Afula, Israel
Meir Medical Center
Kfar Saba, Israel
Souraski Medical Center
Tel Aviv, Israel
To evaluate the safety and tolerability of ARK-E021 topical foam in subjects with acne vulgaris.
Subject safety will be assessed following treatment using measurements of the following variables: * Physical examination. * Vital Signs (HR, BP, Body temperature). * Adverse events recording. * Concomitant medications.
Time frame: Baseline through week 16.
To evaluate the efficacy of ARK-E021 topical foam in subjects with acne vulgaris.
Subject efficacy will be assessed following treatment using measurements of the following variables: * Lesion count (inflammatory/non inflammatory and total). * Investigator global assessment (IGA; grade 0-4). * Lesion documentation by photographs (optional).
Time frame: Baseline through week 16.
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