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Verapamil vs Steroid to Prevent Keloid Recurrence

Primary Purpose

Keloid Scars

Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Verapamil
Kenalog 10
Sponsored by
The University of Western Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keloid Scars

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Perth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Verapamil

Kenalog 10

Arm Description

Verapamil 2.5 mg/mL injection sc intralesionally

Kenalog 10 mg/mL injection sc intralesionally

Outcomes

Primary Outcome Measures

Keloid recurrence

Secondary Outcome Measures

Vancouver Scar Scale Score

Full Information

First Posted
October 30, 2012
Last Updated
June 9, 2015
Sponsor
The University of Western Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01720056
Brief Title
Verapamil vs Steroid to Prevent Keloid Recurrence
Official Title
Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Objective of study achieved after interim analysis.
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Western Australia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid Scars

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verapamil
Arm Type
Active Comparator
Arm Description
Verapamil 2.5 mg/mL injection sc intralesionally
Arm Title
Kenalog 10
Arm Type
Active Comparator
Arm Description
Kenalog 10 mg/mL injection sc intralesionally
Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Type
Drug
Intervention Name(s)
Kenalog 10
Primary Outcome Measure Information:
Title
Keloid recurrence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Vancouver Scar Scale Score
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiona M Wood, Professor
Organizational Affiliation
The University of Western Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia

12. IPD Sharing Statement

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Verapamil vs Steroid to Prevent Keloid Recurrence

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