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

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ClinicalTrials.gov Identifier: NCT02823236
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : July 14, 2017
Sponsor:
Collaborator:
Grupo Medifarma, S. A. de C. V.
Information provided by (Responsible Party):
Centro Dermatológico Dr. Ladislao de la Pascua

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.

Condition or disease Intervention/treatment Phase
Keloid Drug: Topical Pirfenidone Drug: Triamcinolone + Pirfenidone Drug: Intralesional Triamcinolone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial
Actual Study Start Date : October 24, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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 Name: 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 Name: 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 Name: Kenalog + KitosCell




Primary Outcome Measures :
  1. Change in Keloid Scar Assessment [ Time Frame: 0 and 24 weeks ]
    Assessment using the Vancouver Scar Scale (VSS)

  2. Change in Keloid Scar Assessment by Patients [ Time Frame: 0 and 24 weeks ]
    Assessment using the Patient and Observer Scar Assessment Scale (POSAS)


Secondary Outcome Measures :
  1. Occurrence of adverse effects [ Time Frame: Every 4 weeks after the beginning of the intervention up to 52 weeks ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Quality of life of the patient [ Time Frame: 24 weeks ]
    Dermatology Life Quality Index

  3. Recurrence defined as an increase size of the keloid scar at week 52 [ Time Frame: 52 weeks ]
    Number of patients with an increase size of the keloid scar compared with the size obtained at week 24



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823236


Contacts
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Contact: Martha Alejandra Morales-Sánchez, MD, MSc 55387033 ext 312 mmoraless@sersalud.df.gob.mx

Locations
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Mexico
Centro Dermatológico "Dr. Ladislao de la Pascua" Recruiting
Mexico City, Mexico, 06780
Contact: Martha Alejandra Morales-Sánchez, MD, MSc.    55387033 ext 312    mmoraless@sersalud.df.gob.mx   
Sponsors and Collaborators
Centro Dermatológico Dr. Ladislao de la Pascua
Grupo Medifarma, S. A. de C. V.
Investigators
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Principal Investigator: Martha Alejandra Morales-Sánchez, MD, MSc Centro Dermatológico Dr. Ladislao de la Pascua

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Responsible Party: Centro Dermatológico Dr. Ladislao de la Pascua
ClinicalTrials.gov Identifier: NCT02823236     History of Changes
Other Study ID Numbers: 90/15
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Centro Dermatológico Dr. Ladislao de la Pascua:
Keloid
Scar

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Pirfenidone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Antirheumatic Agents
Antineoplastic Agents