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

Phase 2

• Conditions: Acne Vulgaris
• Interventions: Device: Oplon Active Patch; Device: Placebo Patch

• Registration Number: NCT01260766
• Lead Sponsor: Oplon-Pure Science Ltd.

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.

Study Timeline

• Status Verified: 2010-12
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Last Update Submitted: 2010-12-16
• Last Update Posted: 2010-12-17
• Study Start: 2011-01
• Primary Completion: 2011-04
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: Oplon Active Patch	Oplon Active Patch	-
Placebo Comparator: Placebo patch	Placebo Patch	-

Primary Outcome Measures

Name	Time	Method
Severity Score of lesion	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

Name	Time	Method
Severity Score of lesion	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

Trial Locations

Locations (1)

Dermatology Clinic; 🇮🇱 Natanya, Israel