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Verapamil vs Steroid to Prevent Keloid Recurrence

This study is currently recruiting participants.
Verified October 2012 by The University of Western Australia
Sponsor:
Information provided by (Responsible Party):
Fiona M. Wood, The University of Western Australia
ClinicalTrials.gov Identifier:
NCT01720056
First received: October 30, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • Keloid recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vancouver Scar Scale Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720056

Contacts
Contact: Patricia L. Danielsen, MD, PhD 0448697737 patriciadanielsen@yahoo.dk
Contact: Hilary Wallace, Dr. hilary.wallace@uwa.edu.au

Locations
Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6001
Contact: Fiona M Wood, Professor            
Sub-Investigator: Patricia L. Danielsen, MD, PhD            
Sub-Investigator: Hilary Wallace, Dr.            
Sub-Investigator: Suzanne Rea, Professor            
Sponsors and Collaborators
The University of Western Australia
Investigators
Principal Investigator: Fiona M Wood, Professor The University of Western Australia
  More Information

No publications provided

Responsible Party: Fiona M. Wood, Prof. Wood, The University of Western Australia
ClinicalTrials.gov Identifier: NCT01720056     History of Changes
Other Study ID Numbers: EC 067/2012
Study First Received: October 30, 2012
Last Updated: October 30, 2012
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Keloid
Recurrence
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Disease Attributes
Verapamil
Diltiazem
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013