Acne Treatment With Active Oplon's Patches - 15-18 Years Old

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2010 by Oplon-Pure Science Ltd..
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by:

Oplon-Pure Science Ltd.

ClinicalTrials.gov Identifier:

NCT01260766

First received: December 14, 2010

Last updated: December 16, 2010

Last verified: December 2010

History of Changes

Purpose

The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.

Condition	Intervention	Phase
Acne Vulgaris	Device: Oplon Active Patch Device: Placebo Patch	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide

U.S. FDA Resources

Further study details as provided by Oplon-Pure Science Ltd.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	50
Study Start Date:	January 2011
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260766

Contacts


Contact: Avner Shemer, M.D.	: +972-524575677	ashemer1@gmail.com

Locations


Israel
Dermatology Clinic	Recruiting
Natanya, Israel
Contact: Avner Shemer, M.D. +972-524575677 ashemer1@gmail.com

Sponsors and Collaborators

Oplon-Pure Science Ltd.

Investigators


Principal Investigator:	Avner Shemer, M.D.	Laniado Medical Center

More Information


Responsible Party:	Avner Shemer M.D., Dermatology Clinic
ClinicalTrials.gov Identifier:	NCT01260766 History of Changes
Other Study ID Numbers:	OP003
Study First Received:	December 14, 2010
Last Updated:	December 16, 2010

Additional relevant MeSH terms:


Acne Vulgaris Acneiform Eruptions Skin Diseases	Sebaceous Gland Diseases Benzoyl Peroxide Dermatologic Agents

ClinicalTrials.gov processed this record on September 21, 2017

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