Keloidscars MedDRA version: 16.1 Level: LLT Classification code 10023329 Term: Keloid System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Lederspan
Product Name: Lederspan
Product Code: Lederspan
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: TRIAMCINOLONE HEXACETONIDE
CAS Number
Sponsors
Tays
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Over 18 year old, healthy person with keloid which can be treated with injections and who are already treating in TAYS plastic surgery outpatient clinic. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Preganancy, planning pregnanacy, liver or kidney failure, local or systemic infection and changes of blood count.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the efficacy of intralesional 5-FU injections in keloid treatment.;Secondary Objective: Investigate the efficacy of intradermal triamcinolone in keloid treatment.;Primary end point(s): after 3 injections, 12 week, 6 months and 12 months follow up and clinical assessement;Timepoint(s) of evaluation of this end point: 12 weeks, 6 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): same as primary end points;Timepoint(s) of evaluation of this end point: 12 weeks, 6 months, 12 months | — |
Countries
Finland
Contacts
Public ContactKrstiina Hietanen
Tays
Outcome results
None listed