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Verapamil vs Steroid to Prevent Keloid Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01720056
Recruitment Status : Terminated (Objective of study achieved after interim analysis.)
First Posted : November 1, 2012
Last Update Posted : June 10, 2015
Information provided by (Responsible Party):
Fiona M. Wood, 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.

Condition or disease Intervention/treatment Phase
Keloid Scars Drug: Verapamil Drug: Kenalog 10 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01720056

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Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
The University of Western Australia
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Principal Investigator: Fiona M Wood, Professor The University of Western Australia
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Responsible Party: Fiona M. Wood, Prof. Wood, The University of Western Australia Identifier: NCT01720056    
Other Study ID Numbers: EC 067/2012
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Collagen Diseases
Connective Tissue Diseases
Triamcinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents