Acne Treatment With Active Oplon's Patches

June 9, 2011 updated by: Oplon-Pure Science Ltd.

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Natanya, Israel
        • Dermatology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator: Oplon Active Patch
Patches are placed over acne lesion overnight. Treatment is a single treatment.
Placebo Comparator: Placebo Comparator: Placebo patch
same as active patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Severity Score of lesion [Time Frame: 24 hours following patch removal]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Severity Score of lesion [Time Frame: 12 hours with the patch]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • OP002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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