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Acne Treatment With Active Oplon's Patches

This study has been completed.
Information provided by:
Oplon-Pure Science Ltd. Identifier:
First received: August 11, 2010
Last updated: June 9, 2011
Last verified: June 2011
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: Placebo Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid

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] ]

    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] ]

    Lesions were ranked by investigator according to severity whereas:

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

Estimated Enrollment: 40
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator: Oplon Active Patch Device: Oplon Active Patch
Patches are placed over acne lesion overnight. Treatment is a single treatment.
Placebo Comparator: Placebo Comparator: Placebo patch Device: Placebo Patch
same as active 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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01180543

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

Responsible Party: Avner Shemer M.D., Dermatology Clinic Identifier: NCT01180543     History of Changes
Other Study ID Numbers: OP002
Study First Received: August 11, 2010
Last Updated: June 9, 2011

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents processed this record on May 25, 2017