Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
NCT ID: NCT02823236
Last Updated: 2017-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
102 participants
INTERVENTIONAL
2016-10-24
2020-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intralesional Triamcinolone
A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months.
Intralesional Triamcinolone
Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.
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.
Topical Pirfenidone
Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Keloids less than 5 years old
* Keloids in trunk
Exclusion Criteria
* 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
18 Years
59 Years
ALL
No
Sponsors
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Grupo Medifarma, S. A. de C. V.
INDUSTRY
Centro Dermatológico Dr. Ladislao de la Pascua
OTHER
Responsible Party
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Principal Investigators
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Martha Alejandra Morales-Sánchez, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Centro Dermatológico Dr. Ladislao de la Pascua
Locations
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Centro Dermatológico "Dr. Ladislao de la Pascua"
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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90/15
Identifier Type: -
Identifier Source: org_study_id
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