Effect of Transparent, Self-drying Silicone Gel on the Tr... | NCT01078428

Studies
Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars

NCT01078428

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jan 28, 2014Estimated

Enrollment

38Actual

Phase

Phase 4

Conditions

Keloids
Hypertrophic Scars

Interventions

Topical silicone gel
Vaseline

Countries

Thailand

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

ID	Type	Description	Link
125/2552(EC4)	Other Identifier	Siriraj Institutional Review Board

Status Module

Record Verification Date

Jan 2014

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

Jan 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Feb 27, 2010

First Submission Date that Met QC Criteria

Mar 1, 2010

First Posted Date

Mar 2, 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

Jan 24, 2014

Last Update Posted Date

Jan 28, 2014Estimated

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

Keloids and hypertrophic scars are a common subject of dermatologic consultations. Therapeutic management of such conditions remains challenging because of their high rate of recurrence and lack of curative treatment.

Detailed Description

Silicone gel Sheeting (SGS) is one treatment modality that has proven effective for treatment of hypertrophic scar. One disadvantage of SGS is its application technique. To be effective, SGS must be applied on the scar for at least 12 hours daily. Topical silicone gel is a novel therapy that has shown promising result on scar prevention. However, the efficacy and safety of topical silicone gel for treatment of hypertrophic scar has not been confirmed.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Silicone gel	Active Comparator	Gel containing silicone gel	Other: Topical silicone gel
Vaseline	Placebo Comparator	Gel containing petrolatum gel	Other: Vaseline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical silicone gel	Other	Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks	Silicone gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scar thickness		1, 2 and 5 months after initiation of treatment

Secondary Outcomes

Measure	Description	Time Frame
Clinical assessment on overall scar appearance		1, 2 and 5 months after initiation of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects at least 18 years old
subjects with hypertrophic abdominal scar
Have not received treatment on the scar at least 1 month prior to the enrollment.

Exclusion Criteria:

subject who has previous history of silicone allergy
subject who smoke cigarette
subject who was treated with x-rays irradiation in the past

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Woraphong - Manuskiatti, M.D.	Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital		Bangkoknoi	Bangkok	10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17727466	Background	Kloeters O, Tandara A, Mustoe TA. Hypertrophic scar model in the rabbit ear: a reproducible model for studying scar tissue behavior with new observations on silicone gel sheeting for scar reduction. Wound Repair Regen. 2007 Sep-Oct;15 Suppl 1:S40-5. doi: 10.1111/j.1524-475X.2007.00224.x.
16756266	Background

ID	Term
D007627	Keloid
D017439	Cicatrix, Hypertrophic

ID	Term
D003095	Collagen Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D002921	Cicatrix

ID	Term
D020034	Silicone Gels
D010577	Petrolatum

ID	Term
D012828	Silicones
D012833	Siloxanes
D017646	Organosilicon Compounds
D009930	Organic Chemicals