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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
ARK-E021 5%
ARK-E021 10%
Placebo
Sponsored by
M. Arkin 1999 Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Topical, Foam

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HaEmek Medical Center
  • Meir Medical Center
  • Souraski Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ARK-E021 5% foam

ARK-E021 10% foam

Placebo foam

Arm Description

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
December 15, 2011
Last Updated
December 1, 2013
Sponsor
M. Arkin 1999 Ltd.
Collaborators
Vyne Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01494285
Brief Title
Clinical Study to Evaluate Tolerability and Safety of ARK-E021 Foam and to Monitor Clinical Effect in Acne Vulgaris Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M. Arkin 1999 Ltd.
Collaborators
Vyne Therapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris, Topical, Foam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARK-E021 5% foam
Arm Type
Experimental
Arm Title
ARK-E021 10% foam
Arm Type
Experimental
Arm Title
Placebo foam
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARK-E021 5%
Other Intervention Name(s)
Not yet marketed
Intervention Description
Topically applied once daily at bedtime
Intervention Type
Drug
Intervention Name(s)
ARK-E021 10%
Other Intervention Name(s)
Not yet marketed
Intervention Description
Topically applied once daily at bedtime
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Not marketed
Intervention Description
Topically applied once daily at bedtime
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of ARK-E021 topical foam in subjects with acne vulgaris.
Description
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.
Title
To evaluate the efficacy of ARK-E021 topical foam in subjects with acne vulgaris.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Facility Name
Souraski Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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