Keloid Scars Clinical Trial
Official title:
Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
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.
| Status | Terminated |
| Enrollment | 14 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Perth Hospital | Perth | Western Australia |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Western Australia |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Keloid recurrence | 1 year | No | |
| Secondary | Vancouver Scar Scale Score | 1 year | No |