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

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Oplon Active Patch
Placebo Patch
Sponsored by
Oplon-Pure Science Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
December 14, 2010
Last Updated
December 16, 2010
Sponsor
Oplon-Pure Science Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01260766
Brief Title
Acne Treatment With Active Oplon's Patches - 15-18 Years Old
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
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

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
50 (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
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avner Shemer, M.D.
Phone
: +972-524575677
Email
ashemer1@gmail.com
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avner Shemer, M.D.
Phone
+972-524575677
Email
ashemer1@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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