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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

Page last updated: August 23, 2015

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