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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Oplon-Pure Science Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Oplon-Pure Science Ltd.
ClinicalTrials.gov Identifier:
NCT01260766
First received: December 14, 2010
Last updated: December 16, 2010
Last verified: December 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: Placebo Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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] ] [ 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 ]

    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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260766

Contacts
Contact: Avner Shemer, M.D. : +972-524575677 ashemer1@gmail.com

Locations
Israel
Dermatology Clinic Recruiting
Natanya, Israel
Contact: Avner Shemer, M.D.    +972-524575677    ashemer1@gmail.com   
Sponsors and Collaborators
Oplon-Pure Science Ltd.
Investigators
Principal Investigator: Avner Shemer, M.D. Laniado Medical Center
  More Information

No publications provided

Responsible Party: Avner Shemer M.D., Dermatology Clinic
ClinicalTrials.gov Identifier: NCT01260766     History of Changes
Other Study ID Numbers: OP003
Study First Received: December 14, 2010
Last Updated: December 16, 2010
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014