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Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars (LADISLAO)

Primary Purpose

Keloid

Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Topical Pirfenidone
Triamcinolone + Pirfenidone
Intralesional Triamcinolone
Sponsored by
Centro Dermatológico Dr. Ladislao de la Pascua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid focused on measuring Keloid, Scar

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Centro Dermatológico "Dr. Ladislao de la Pascua"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Intralesional Triamcinolone

Topical Pirfenidone

Triamcinolone + Pirfenidone

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Change in Keloid Scar Assessment
Assessment using the Vancouver Scar Scale (VSS)
Change in Keloid Scar Assessment by Patients
Assessment using the Patient and Observer Scar Assessment Scale (POSAS)

Secondary Outcome Measures

Occurrence of adverse effects
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Quality of life of the patient
Dermatology Life Quality Index
Recurrence defined as an increase size of the keloid scar at week 52
Number of patients with an increase size of the keloid scar compared with the size obtained at week 24

Full Information

First Posted
June 27, 2016
Last Updated
July 12, 2017
Sponsor
Centro Dermatológico Dr. Ladislao de la Pascua
Collaborators
Grupo Medifarma, S. A. de C. V.
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1. Study Identification

Unique Protocol Identification Number
NCT02823236
Brief Title
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
Acronym
LADISLAO
Official Title
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 24, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Dermatológico Dr. Ladislao de la Pascua
Collaborators
Grupo Medifarma, S. A. de C. V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. The interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. The scar size will be measure at weeks 12, 24 and 52.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Keloid, Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intralesional Triamcinolone
Arm Type
Active Comparator
Arm Description
A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months.
Arm Title
Topical Pirfenidone
Arm Type
Experimental
Arm Description
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.
Arm Title
Triamcinolone + Pirfenidone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Topical Pirfenidone
Other Intervention Name(s)
KitosCell
Intervention Description
Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone + Pirfenidone
Other Intervention Name(s)
Kenalog + KitosCell
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intralesional Triamcinolone
Other Intervention Name(s)
Kenalog
Intervention Description
Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.
Primary Outcome Measure Information:
Title
Change in Keloid Scar Assessment
Description
Assessment using the Vancouver Scar Scale (VSS)
Time Frame
0 and 24 weeks
Title
Change in Keloid Scar Assessment by Patients
Description
Assessment using the Patient and Observer Scar Assessment Scale (POSAS)
Time Frame
0 and 24 weeks
Secondary Outcome Measure Information:
Title
Occurrence of adverse effects
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Every 4 weeks after the beginning of the intervention up to 52 weeks
Title
Quality of life of the patient
Description
Dermatology Life Quality Index
Time Frame
24 weeks
Title
Recurrence defined as an increase size of the keloid scar at week 52
Description
Number of patients with an increase size of the keloid scar compared with the size obtained at week 24
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Keloids size equal or major than 1 cm Keloids less than 5 years old Keloids in trunk Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Alejandra Morales-Sánchez, MD, MSc
Phone
55387033
Ext
312
Email
mmoraless@sersalud.df.gob.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Alejandra Morales-Sánchez, MD, MSc
Organizational Affiliation
Centro Dermatológico Dr. Ladislao de la Pascua
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Dermatológico "Dr. Ladislao de la Pascua"
City
Mexico City
ZIP/Postal Code
06780
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Alejandra Morales-Sánchez, MD, MSc.
Phone
55387033
Ext
312
Email
mmoraless@sersalud.df.gob.mx

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars

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