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
About this trial
This is an interventional prevention trial for Keloid Scars
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
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
NCT ID
NCT01720056
First Posted
October 30, 2012
Last Updated
June 9, 2015
Sponsor
The University of Western Australia
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
Learn more about this trial
Verapamil vs Steroid to Prevent Keloid Recurrence
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