NCT01720056

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

October 30, 2012

Last Update Submit

June 9, 2015

Conditions

Keloid Scars

Outcome Measures

Primary Outcomes (1)

  • Keloid recurrence

    1 year

Secondary Outcomes (1)

  • Vancouver Scar Scale Score

    1 year

Study Arms (2)

Verapamil

ACTIVE COMPARATOR

Verapamil 2.5 mg/mL injection sc intralesionally

Drug: Verapamil

Kenalog 10

ACTIVE COMPARATOR

Kenalog 10 mg/mL injection sc intralesionally

Drug: Kenalog 10

Interventions

VerapamilDRUG
Verapamil
Kenalog 10DRUG
Kenalog 10

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Perth Hospital

Perth, Western Australia, 6001, Australia

Location

MeSH Terms

Conditions

Keloid

Interventions

VerapamilTriamcinolone

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic ChemicalsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Fiona M Wood, Professor

    The University of Western Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Wood

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 1, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

AU(1)