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Verapamil vs Steroid to Prevent Keloid Recurrence

This study has been terminated.
(Objective of study achieved after interim analysis.)
Information provided by (Responsible Party):
Fiona M. Wood, The University of Western Australia Identifier:
First received: October 30, 2012
Last updated: June 9, 2015
Last verified: June 2015

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.

Condition Intervention Phase
Keloid Scars Drug: Verapamil Drug: Kenalog 10 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal

Resource links provided by NLM:

Further study details as provided by Fiona M. Wood, The University of Western Australia:

Primary Outcome Measures:
  • Keloid recurrence [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Vancouver Scar Scale Score [ Time Frame: 1 year ]

Enrollment: 14
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Verapamil
Verapamil 2.5 mg/mL injection sc intralesionally
Drug: Verapamil
Active Comparator: Kenalog 10
Kenalog 10 mg/mL injection sc intralesionally
Drug: Kenalog 10


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01720056

Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
The University of Western Australia
Principal Investigator: Fiona M Wood, Professor The University of Western Australia
  More Information

Responsible Party: Fiona M. Wood, Prof. Wood, The University of Western Australia Identifier: NCT01720056     History of Changes
Other Study ID Numbers: EC 067/2012
Study First Received: October 30, 2012
Last Updated: June 9, 2015

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Collagen Diseases
Connective Tissue Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents processed this record on June 22, 2017