Acne Treatment With Active Patches Which Contains Azelaic... | NCT01179633

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

NCT01179633

Sponsor

Oplon-Pure Science Ltd.

Status

Completed

Last Update Posted

Aug 11, 2010Estimated

Enrollment

35Actual

Phase

Phase 1Phase 2

Conditions

Acne Vulgaris

Interventions

OPLON active patch
Sham patch

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Aug 5, 2010

First Submission Date that Met QC Criteria

Aug 10, 2010

First Posted Date

Aug 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2010

Last Update Posted Date

Aug 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oplon Active Patch	Active Comparator		Device: OPLON active patch
Placebo patch	Placebo Comparator		Device: Sham patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPLON active patch	Device		Oplon Active Patch
Sham patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Severity Score of lesion	0-clear, 1-mild, 2-moderate, 3-sever	•Severity Score of lesion [Time Frame: 12 hours with the patch]

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acne Vulgaris
Over 18 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Avner Shemer, MD	Laniado Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dermatology Clinic		Netanya			Israel

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided