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Acne Treatment With Active Oplon's Patches - 15-18 Years Old

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Oplon-Pure Science Ltd..
Recruitment status was:  Not yet recruiting
Information provided by:
Oplon-Pure Science Ltd. Identifier:
First received: December 14, 2010
Last updated: December 16, 2010
Last verified: December 2010
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: 50
Study Start Date: January 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (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:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acne Vulgaris
  • Over 15 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 identifier: NCT01260766

Contact: Avner Shemer, M.D. : +972-524575677

Dermatology Clinic Recruiting
Natanya, Israel
Contact: Avner Shemer, M.D.    +972-524575677   
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: NCT01260766     History of Changes
Other Study ID Numbers: OP003
Study First Received: December 14, 2010
Last Updated: December 16, 2010

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