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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

Tracking Information
First Submitted Date  ICMJE June 27, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date July 14, 2017
Actual Study Start Date  ICMJE October 24, 2016
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • Change in Keloid Scar Assessment [ Time Frame: 0 and 24 weeks ]
    Assessment using the Vancouver Scar Scale (VSS)
  • Change in Keloid Scar Assessment by Patients [ Time Frame: 0 and 24 weeks ]
    Assessment using the Patient and Observer Scar Assessment Scale (POSAS)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02823236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • 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
  • Quality of life of the patient [ Time Frame: 24 weeks ]
    Dermatology Life Quality Index
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
Official Title  ICMJE Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Keloid
Intervention  ICMJE
  • 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
  • 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
  • Drug: Intralesional Triamcinolone
    Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.
    Other Name: Kenalog
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Intralesional Triamcinolone
  • 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.
    Intervention: Drug: Topical Pirfenidone
  • 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.
    Intervention: Drug: Triamcinolone + Pirfenidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2016)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Martha Alejandra Morales-Sánchez, MD, MSc 55387033 ext 312 mmoraless@sersalud.df.gob.mx
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02823236
Other Study ID Numbers  ICMJE 90/15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Centro Dermatológico Dr. Ladislao de la Pascua
Study Sponsor  ICMJE Centro Dermatológico Dr. Ladislao de la Pascua
Collaborators  ICMJE Grupo Medifarma, S. A. de C. V.
Investigators  ICMJE
Principal Investigator: Martha Alejandra Morales-Sánchez, MD, MSc Centro Dermatológico Dr. Ladislao de la Pascua
PRS Account Centro Dermatológico Dr. Ladislao de la Pascua
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP