NCT01180543

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

2 months

First QC Date

August 11, 2010

Last Update Submit

June 9, 2011

Conditions

Acne Vulgaris

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 COMPARATOR
Device: Oplon Active Patch

Placebo Comparator: Placebo patch

PLACEBO COMPARATOR
Device: Placebo Patch

Interventions

Oplon Active PatchDEVICE

Patches are placed over acne lesion overnight. Treatment is a single treatment.

Active Comparator: Oplon Active Patch
Placebo PatchDEVICE

same as active patch

Placebo Comparator: Placebo patch

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acne Vulgaris
  • Over 18 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

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Avner Shemer, M.D.

    Laniado Medical Center

    PRINCIPAL INVESTIGATOR

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

August 11, 2010

First Posted

August 12, 2010

Study Start

August 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

IL(1)