Verapamil vs Steroid to Prevent Keloid Recurrence
Information source: The University of Western Australia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keloid Scars
Intervention: Verapamil (Drug); Kenalog 10 (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: The University of Western Australia Official(s) and/or principal investigator(s): Fiona M Wood, Professor, Principal Investigator, Affiliation: The University of Western Australia
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.
Clinical Details
Official title: Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Keloid recurrence
Secondary outcome: Vancouver Scar Scale Score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Royal Perth Hospital, Perth, Western Australia 6001, Australia
Additional Information
Starting date: October 2012
Last updated: June 9, 2015
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