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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014