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

This study is currently recruiting participants.
Verified August 2012 by M. Arkin 1999 Ltd.
Sponsor:
Collaborator:
Foamix Ltd.
Information provided by (Responsible Party):
M. Arkin 1999 Ltd.
ClinicalTrials.gov Identifier:
NCT01494285
First received: December 15, 2011
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
 Drug: ARK-E021 5%
Drug: ARK-E021 10%
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by M. Arkin 1999 Ltd.:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of ARK-E021 topical foam in subjects with acne vulgaris. [ Time Frame: Baseline through week 16. ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: Baseline through week 16. ] [ Designated as safety issue: No ]

    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).


Estimated Enrollment: 144
Study Start Date: June 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARK-E021 5% foam Drug: ARK-E021 5%
Topically applied once daily at bedtime
Other Name: Not yet marketed
Experimental: ARK-E021 10% foam Drug: ARK-E021 10%
Topically applied once daily at bedtime
Other Name: Not yet marketed
Placebo Comparator: Placebo foam Drug: Placebo
Topically applied once daily at bedtime
Other Name: Not marketed

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.

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494285

Locations
Israel
HaEmek Medical Center Not yet recruiting
Afula, Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: B. Amihai, MD         yulia.ssc@gmail.com    
Souraski Medical Center Recruiting
Tel Aviv, Israel
Contact: Y. Roytman, M.Sc.         yulia.ssc@gmail.com    
Sponsors and Collaborators
M. Arkin 1999 Ltd.
Foamix Ltd.
  More Information

No publications provided

Responsible Party: M. Arkin 1999 Ltd.
ClinicalTrials.gov Identifier: NCT01494285     History of Changes
Other Study ID Numbers: MA1001
Study First Received: December 15, 2011
Last Updated: August 1, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by M. Arkin 1999 Ltd.:
Acne Vulgaris
Topical
Foam

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on May 22, 2013