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

Study Overview
=================
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 moderate acne vulgaris.

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 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.

Official Title
-----------------
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.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: ARK-E021 5%
* Drug: ARK-E021 10%
* Drug: Placebo


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARK-E021 5% foam<br> | Drug: ARK-E021 5%<br>* Topically applied once daily at bedtime<br>* Other names: Not yet marketed;|
| Experimental: ARK-E021 10% foam<br> | Drug: ARK-E021 10%<br>* Topically applied once daily at bedtime<br>* Other names: Not yet marketed;|
| Placebo Comparator: Placebo foam<br> | Drug: Placebo<br>* Topically applied once daily at bedtime<br>* Other names: Not marketed;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Baseline through week 16. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne Vulgaris, Topical, Foam