Verapamil vs Steroid to Prevent Keloid Recurrence

June 9, 2015 updated by: Fiona M. Wood, The University of Western Australia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Royal Perth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Keloid recurrence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Vancouver Scar Scale Score
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Western Australia

Investigators

  • Principal Investigator: Fiona M Wood, Professor, The University of Western Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

October 30, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 067/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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