Verapamil vs Steroid to Prevent Keloid Recurrence

Phase 4

Terminated

• Conditions: Keloid Scars
• Interventions: Drug: Kenalog 10; Drug: Verapamil

• Registration Number: NCT01720056
• Lead Sponsor: The University of Western Australia

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 available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-30
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-11-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kenalog 10	Kenalog 10	Kenalog 10 mg/mL injection sc intralesionally
Verapamil	Verapamil	Verapamil 2.5 mg/mL injection sc intralesionally

Primary Outcome Measures

Name	Time	Method
Keloid recurrence	1 year

Secondary Outcome Measures

Name	Time	Method
Vancouver Scar Scale Score	1 year

Trial Locations

Locations (1)

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia