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

Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial

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.

Study Overview

• Status: Unknown
• Conditions: Keloid
• Intervention / Treatment: Drug: Intralesional Triamcinolone; Drug: Topical Pirfenidone; Drug: Triamcinolone + Pirfenidone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06780
    • Recruiting
    • Centro Dermatológico "Dr. Ladislao de la Pascua"
    • Contact: Martha Alejandra Morales-Sánchez, MD, MSc.; Phone Number: 312 55387033; Email: mmoraless@sersalud.df.gob.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intralesional Triamcinolone; A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months.	Drug: Intralesional Triamcinolone; Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.; Other Names: Kenalog
Experimental: Topical Pirfenidone; 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; Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.; Other Names: KitosCell
Experimental: Triamcinolone + Pirfenidone; 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; 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.; Other Names: Kenalog + KitosCell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse effects	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Every 4 weeks after the beginning of the intervention up to 52 weeks
Quality of life of the patient	Dermatology Life Quality Index	24 weeks
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	52 weeks

Collaborators and Investigators

• Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
• Collaborators: Grupo Medifarma, S. A. de C. V.
• Investigators: Principal Investigator: Martha Alejandra Morales-Sánchez, MD, MSc, Centro Dermatológico Dr. Ladislao de la Pascua

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2016
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Scar; Keloid
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pirfenidone; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 90/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided