Back to resultsAcne Treatment With Active Oplon's Patches
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Oplon Active Patch
Placebo Patch
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility 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
Sites / Locations
- Dermatology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Comparator: Oplon Active Patch
Placebo Comparator: Placebo patch
Arm Description
Outcomes
Primary Outcome Measures
Severity Score of lesion
Lesions were ranked by investigator according to severity whereas:
0-clear, 1-mild, 2-moderate, 3-sever
Secondary Outcome Measures
Severity Score of lesion
Lesions were ranked by investigator according to severity whereas:
0-clear, 1-mild, 2-moderate, 3-sever
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01180543
Brief Title
Acne Treatment With Active Oplon's Patches
Official Title
Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oplon-Pure Science Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator: Oplon Active Patch
Arm Type
Active Comparator
Arm Title
Placebo Comparator: Placebo patch
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Oplon Active Patch
Intervention Description
Patches are placed over acne lesion overnight. Treatment is a single treatment.
Intervention Type
Device
Intervention Name(s)
Placebo Patch
Intervention Description
same as active patch
Primary Outcome Measure Information:
Title
Severity Score of lesion
Description
Lesions were ranked by investigator according to severity whereas:
0-clear, 1-mild, 2-moderate, 3-sever
Time Frame
Severity Score of lesion [Time Frame: 24 hours following patch removal]
Secondary Outcome Measure Information:
Title
Severity Score of lesion
Description
Lesions were ranked by investigator according to severity whereas:
0-clear, 1-mild, 2-moderate, 3-sever
Time Frame
Severity Score of lesion [Time Frame: 12 hours with the patch]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avner Shemer, M.D.
Organizational Affiliation
Laniado Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Clinic
City
Natanya
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Acne Treatment With Active Oplon's Patches
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