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

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
|
- 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: 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

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Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Avner Shemer, M.D. | : +972-524575677 | ashemer1@gmail.com |
Israel | |
Dermatology Clinic | Recruiting |
Natanya, Israel | |
Contact: Avner Shemer, M.D. +972-524575677 ashemer1@gmail.com |
Principal Investigator: | Avner Shemer, M.D. | Laniado Medical Center |
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 |