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

Keloid Clinical Trial

— LADISLAO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02823236
• Other study ID #: 90/15
• Status: Recruiting
• Phase: Phase 3
• First received: June 27, 2016
• Last updated: July 12, 2017
• Start date: October 24, 2016
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2017
• Source: Centro Dermatológico Dr. Ladislao de la Pascua
• Contact: Martha Alejandra Morales-Sánchez, MD, MSc
• Phone: 55387033
• Email: mmoraless[@]sersalud.df.gob.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: May 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• Topical Pirfenidone
Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.
• 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.
• Intralesional Triamcinolone
Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.

Locations

Country	Name	City	State
Mexico	Centro Dermatológico "Dr. Ladislao de la Pascua"	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Centro Dermatológico Dr. Ladislao de la Pascua	Grupo Medifarma, S. A. de C. V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Keloid Scar Assessment	Assessment using the Vancouver Scar Scale (VSS)	0 and 24 weeks
Primary	Change in Keloid Scar Assessment by Patients	Assessment using the Patient and Observer Scar Assessment Scale (POSAS)	0 and 24 weeks
Secondary	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
Secondary	Quality of life of the patient	Dermatology Life Quality Index	24 weeks
Secondary	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