Verapamil vs Steroid to Prevent Keloid Recurrence

The University of Western Australia

Status and phase: Terminated; Phase 4

Conditions: Keloid Scars

Treatments: Drug: Verapamil; Drug: Kenalog 10

Study type: Interventional

Funder types: Other

Identifiers

NCT01720056

EC 067/2012

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

14 participants in 2 patient groups

Verapamil

Active Comparator group

Description:

Verapamil 2.5 mg/mL injection sc intralesionally

Treatment:

Drug: Verapamil

Kenalog 10

Active Comparator group

Description:

Kenalog 10 mg/mL injection sc intralesionally

Treatment:

Drug: Kenalog 10