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Acne Treatment With Active Oplon's Patches

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180543
First Posted: August 12, 2010
Last Update Posted: June 10, 2011
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.
August 11, 2010
August 12, 2010
June 10, 2011
August 2010
October 2010   (Final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01180543 on ClinicalTrials.gov Archive Site
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

Same as current
Not Provided
Not Provided
 
Acne Treatment With Active Oplon's Patches
Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.
Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acne Vulgaris
  • Device: Oplon Active Patch
    Patches are placed over acne lesion overnight. Treatment is a single treatment.
  • Device: Placebo Patch
    same as active patch
  • Active Comparator: Active Comparator: Oplon Active Patch
    Intervention: Device: Oplon Active Patch
  • Placebo Comparator: Placebo Comparator: Placebo patch
    Intervention: Device: Placebo Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2010
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01180543
OP002
Yes
Not Provided
Not Provided
Avner Shemer M.D., Dermatology Clinic
Oplon-Pure Science Ltd.
Not Provided
Principal Investigator: Avner Shemer, M.D. Laniado Medical Center
Oplon-Pure Science Ltd.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP