Acne Treatment With Active Oplon's Patches - 15-18 Years Old
Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 17, 2010
December 1, 2010
3 months
December 14, 2010
December 16, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
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]
Secondary Outcomes (1)
Severity Score of lesion
Severity Score of lesion [Time Frame: 12 hours with the patch]
Study Arms (2)
Active Comparator: Oplon Active Patch
ACTIVE COMPARATORPlacebo Comparator: Placebo patch
PLACEBO COMPARATORInterventions
Patches are placed over acne lesion overnight. Treatment is a single treatment.
Eligibility Criteria
You may qualify if:
- Acne Vulgaris
- Over 15 years
- Signing informed consent
You may not qualify if:
- Active treatment of acne
- Change in hormonal therapy
- Antibiotic treatment in a week prior to the experiment
- Sensitive skin
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dermatology Clinic
Netanya, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avner Shemer, M.D.
Laniado Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 15, 2010
Study Start
January 1, 2011
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
December 17, 2010
Record last verified: 2010-12