NCT02823236

Brief Summary

The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated number of persons to be recruited and randomized for the study is 102.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 24, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

3.2 years

First QC Date

June 27, 2016

Last Update Submit

July 12, 2017

Conditions

Keloid

Keywords

KeloidScar

Outcome Measures

Primary Outcomes (2)

  • Change in Keloid Scar Assessment

    Assessment using the Vancouver Scar Scale (VSS)

    0 and 24 weeks

  • Change in Keloid Scar Assessment by Patients

    Assessment using the Patient and Observer Scar Assessment Scale (POSAS)

    0 and 24 weeks

Secondary Outcomes (3)

  • Occurrence of adverse effects

    Every 4 weeks after the beginning of the intervention up to 52 weeks

  • Quality of life of the patient

    24 weeks

  • Recurrence defined as an increase size of the keloid scar at week 52

    52 weeks

Study Arms (3)

Intralesional Triamcinolone

ACTIVE COMPARATOR

A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months.

Drug: Intralesional Triamcinolone

Topical Pirfenidone

EXPERIMENTAL

Dosage commensurate with scar surface to be treated. After washing and drying the affected area, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months.

Drug: Topical Pirfenidone

Triamcinolone + Pirfenidone

EXPERIMENTAL

A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. Simultaneously, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months.

Drug: Triamcinolone + Pirfenidone

Interventions

Topical PirfenidoneDRUG

Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.

Also known as: KitosCell
Topical Pirfenidone
Triamcinolone + PirfenidoneDRUG

Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months. And pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.

Also known as: Kenalog + KitosCell
Triamcinolone + Pirfenidone
Intralesional TriamcinoloneDRUG

Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.

Also known as: Kenalog
Intralesional Triamcinolone

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Keloids size equal or major than 1 cm
  • Keloids less than 5 years old
  • Keloids in trunk

You may not qualify if:

  • Keloid with a surgical indication
  • Hypertrophic scars
  • Scars after burn wounds
  • Pregnancy
  • Lactation
  • Use of systemic chemotherapeutics or chronic use of systemic corticosteroids or immunosuppressive medication
  • Known hypersensitivity for triamcinolone or pirfenidone
  • Severe comorbidity not controlled
  • Inflammatory acne
  • Diabetes Mellitus
  • Hypertension
  • Renal, hepatic or respiratory failure
  • Topical treatment 4 weeks before recruitment
  • Previous treatment with intralesional steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Dermatológico "Dr. Ladislao de la Pascua"

Mexico City, 06780, Mexico

RECRUITING

MeSH Terms

Conditions

KeloidCicatrix

Interventions

pirfenidoneTriamcinoloneTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Martha Alejandra Morales-Sánchez, MD, MSc

    Centro Dermatológico Dr. Ladislao de la Pascua

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Alejandra Morales-Sánchez, MD, MSc

CONTACT

55387033mmoraless@sersalud.df.gob.mx

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 6, 2016

Study Start

October 24, 2016

Primary Completion

December 31, 2019

Study Completion

May 1, 2020

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

ME(1)