Verapamil vs Steroid to Prevent Keloid Recurrence | NCT01720056

Studies
Verapamil vs Steroid to Prevent Keloid Recurrence

NCT01720056

Sponsor

The University of Western Australia

Status

Terminated

Last Update Posted

Jun 10, 2015Estimated

Enrollment

14Actual

Phase

Phase 4

Conditions

Keloid Scars

Interventions

Verapamil
Kenalog 10

Countries

Australia

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Objective of study achieved after interim analysis.

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Oct 30, 2012

First Submission Date that Met QC Criteria

Oct 30, 2012

First Posted Date

Nov 1, 2012Estimated

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

Jun 9, 2015

Last Update Posted Date

Jun 10, 2015Estimated

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

Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil.

Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.

Detailed Description

Not provided

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Verapamil	Active Comparator	Verapamil 2.5 mg/mL injection sc intralesionally	Drug: Verapamil
Kenalog 10	Active Comparator	Kenalog 10 mg/mL injection sc intralesionally	Drug: Kenalog 10

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Verapamil	Drug		Verapamil
Kenalog 10

Measure	Description	Time Frame
Keloid recurrence		1 year

Measure	Description	Time Frame
Vancouver Scar Scale Score		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing surgical removal of keloid
Patient 18 years old or greater
Length of excisional scar after surgical removal of keloid between 2 and 10 cm

Exclusion Criteria:

Keloid in face or hands
Pregnancy or lactation
Dementia
Any heart or pulmonary condition
Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists
Systemic corticosteroidal therapy
Intralesional steroid treatment within 2 months of surgery to remove keloid
Flap surgery
Lesions to face, hands and other cosmetically sensitive areas

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
Fiona M Wood, Professor	The University of Western Australia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Perth Hospital		Perth	Western Australia	6001	Australia

Condition Browse Module

MeSH Terms

ID	Term
D007627	Keloid

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014700	Verapamil
D014221	Triamcinolone

Ancestor Terms

ID	Term
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided