Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid

This study has been completed.
Sponsor:
Information provided by:
Oplon-Pure Science Ltd.
ClinicalTrials.gov Identifier:
NCT01179633
First received: August 5, 2010
Last updated: August 10, 2010
Last verified: August 2010
  Purpose

The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.


Condition Intervention Phase
Acne Vulgaris
Device: OPLON active patch
Device: Sham patch
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Oplon-Pure Science Ltd.:

Primary Outcome Measures:
  • Severity Score of lesion [ Time Frame: •Severity Score of lesion [Time Frame: 24 hours following patch removal] ] [ Designated as safety issue: No ]

    Lesions were ranked by investigator according to severity whereas:

    0-clear, 1-mild, 2-moderate, 3-sever



Secondary Outcome Measures:
  • Severity Score of lesion [ Time Frame: •Severity Score of lesion [Time Frame: 12 hours with the patch] ] [ Designated as safety issue: No ]
    0-clear, 1-mild, 2-moderate, 3-sever


Enrollment: 35
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oplon Active Patch Device: OPLON active patch
Placebo Comparator: Placebo patch Device: Sham patch

Detailed Description:

Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acne Vulgaris
  • Over 18 years
  • Signing informed consent

Exclusion Criteria:

  • Active treatment of acne
  • Change in hormonal therapy
  • Antibiotic treatment in a week prior to the experiment
  • Sensitive skin
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179633

Locations
Israel
Dermatology Clinic
Natanya, Israel
Sponsors and Collaborators
Oplon-Pure Science Ltd.
Investigators
Principal Investigator: Avner Shemer, MD Laniado Medical Center
  More Information

No publications provided

Responsible Party: Dr. Avner Shemer, Dermatology Clinic
ClinicalTrials.gov Identifier: NCT01179633     History of Changes
Other Study ID Numbers: OP001
Study First Received: August 5, 2010
Last Updated: August 10, 2010
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on April 17, 2014