- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01180543
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
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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