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Acne Treatment With Active Oplon's Patches

This study has been completed.
Sponsor:
Information provided by:
Oplon-Pure Science Ltd.
ClinicalTrials.gov Identifier:
NCT01180543
First received: August 11, 2010
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  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:

MedlinePlus related topics: Acne Vitamin C
U.S. FDA Resources

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: 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.

  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: NCT01180543

Locations
Israel
Dermatology Clinic
Natanya, Israel
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: NCT01180543     History of Changes
Other Study ID Numbers: OP002
Study First Received: August 11, 2010
Last Updated: June 9, 2011
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 May 23, 2013