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

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ClinicalTrials.gov Identifier: NCT01260766
Recruitment Status : Unknown
Verified December 2010 by Oplon-Pure Science Ltd..
Recruitment status was:  Not yet recruiting
First Posted : December 15, 2010
Last Update Posted : December 17, 2010
Sponsor:
Information provided by:
Oplon-Pure Science Ltd.

Study Description
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Brief Summary:
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: Oplon Active Patch Device: Placebo Patch Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : January 2011
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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



Eligibility Criteria
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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Avner Shemer M.D., Dermatology Clinic
ClinicalTrials.gov Identifier: NCT01260766     History of Changes
Other Study ID Numbers: OP003
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
 Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents