NCT01078428

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_4

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

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

February 27, 2010

Last Update Submit

January 24, 2014

Conditions

KeloidsHypertrophic Scars

Keywords

Hypertrophic scarsTopical silicone gelScar thicknessScar ColorScar pliabilityScar appearance

Outcome Measures

Primary Outcomes (1)

  • Scar thickness

    1, 2 and 5 months after initiation of treatment

Secondary Outcomes (1)

  • Clinical assessment on overall scar appearance

    1, 2 and 5 months after initiation of treatment

Study Arms (2)

Silicone gel

ACTIVE COMPARATOR

Gel containing silicone gel

Other: Topical silicone gel

Vaseline

PLACEBO COMPARATOR

Gel containing petrolatum gel

Other: Vaseline

Interventions

Topical silicone gelOTHER

Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks

Also known as: Dermatix gel
Silicone gel
VaselineOTHER

Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks

Vaseline

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 17727466BACKGROUND

  • Murison M, James W. Preliminary evaluation of the efficacy of dermatix silicone gel in the reduction of scar elevation and pigmentation. J Plast Reconstr Aesthet Surg. 2006;59(4):437-9. doi: 10.1016/j.bjps.2005.09.037. No abstract available.

    PMID: 16756266BACKGROUND

  • Chan KY, Lau CL, Adeeb SM, Somasundaram S, Nasir-Zahari M. A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound. Plast Reconstr Surg. 2005 Sep 15;116(4):1013-20; discussion 1021-2. doi: 10.1097/01.prs.0000178397.05852.ce.

    PMID: 16163087BACKGROUND

  • Li-Tsang CW, Lau JC, Choi J, Chan CC, Jianan L. A prospective randomized clinical trial to investigate the effect of silicone gel sheeting (Cica-Care) on post-traumatic hypertrophic scar among the Chinese population. Burns. 2006 Sep;32(6):678-83. doi: 10.1016/j.burns.2006.01.016. Epub 2006 Jul 11.

    PMID: 16837136BACKGROUND

MeSH Terms

Conditions

KeloidCicatrix, Hypertrophic

Interventions

Silicone GelsPetrolatum

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureHydrocarbons

Study Officials

  • Woraphong - Manuskiatti, M.D.

    Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2010

First Posted

March 2, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

TH(1)