Verapamil vs Steroid to Prevent Keloid Recurrence

NCT ID: NCT01720056

Last Updated: 2015-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Keloid Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Verapamil

Verapamil 2.5 mg/mL injection sc intralesionally

Group Type ACTIVE_COMPARATOR

Verapamil

Intervention Type DRUG

Kenalog 10

Kenalog 10 mg/mL injection sc intralesionally

Group Type ACTIVE_COMPARATOR

Kenalog 10

Intervention Type DRUG

Interventions

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Verapamil

Intervention Type DRUG

Kenalog 10

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Western Australia

OTHER

Sponsor Role lead

Responsible Party

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Fiona M. Wood

Prof. Wood

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fiona M Wood, Professor

Role: PRINCIPAL_INVESTIGATOR

The University of Western Australia

Locations

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Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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EC 067/2012

Identifier Type: -

Identifier Source: org_study_id

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