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

Acne Vulgaris Clinical Trial

Official title:

Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01260766
• Other study ID #: OP003
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 14, 2010
• Last updated: December 16, 2010
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: December 2010
• Source: Oplon-Pure Science Ltd.
• Contact: Avner Shemer, M.D.
• Phone: : +972-524575677
• Email: ashemer1[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• Oplon Active Patch
Patches are placed over acne lesion overnight. Treatment is a single treatment.
• Placebo Patch
same as active patch

Locations

Country	Name	City	State
Israel	Dermatology Clinic	Natanya

Sponsors (1)

Lead Sponsor	Collaborator
Oplon-Pure Science Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity Score of lesion	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]	No
Secondary	Severity Score of lesion	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]	No