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Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179633
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oplon-Pure Science Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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] ]

    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] ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Avner Shemer, Dermatology Clinic
ClinicalTrials.gov Identifier: NCT01179633     History of Changes
Other Study ID Numbers: OP001
First Submitted: August 5, 2010
First Posted: August 11, 2010
Last Update Posted: August 11, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases