Keloid
Conditions
Interventions
Trade Name: TRIAMCINOLONACETONIDE 40 mg/ml
Product Name: Kenacort A'40'
Product Code: RVG05341
Pharmaceutical Form: Suspension for injection
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Keloid patients, 18-75 yr old, full mental competence, sufficient knowledge of Dutch or English language, keloid suitable for primairy closure after excision, minimum keloid size of 1x1cm. 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 166 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Hypertrofic scars. Keloids less than 1 year existent, burn scars, pregnancy, previous radiotherapy which prohibits additional rediotherapy (only for the group of recurrent keloids), hypersensitivity for lidocaine, adrenaline, triamcinolone. Chronic use (>1 month) of systemic corticosteroids, or immunosuppressive medication (e.g. TNF alfa inhibitors). Use of systemic chemotherapy. Severe morbidity with a life expectancy of less than one year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Keloid disease is a tumorous scar that grows outside of wound borders. It appears as a raised, discoloured lesion that gives rise to aesthetic and psychosocial complaints, itching, and pain. Adequate treatment is indicated, but because of variable results and recurrence of the keloid current therapies are suboptimal. The Objective of the study is to find an effective and permanent treatment against keloid, by comparing current treatments on objective and subjective outcome. We will do this by a randomized controlled intervention study consistent of 2 parts, in oreder to remain close to clinical practice; 1) for primary keloids comparing intralesional cryotherapy with excision combined with corticosteroid injections 2) for recurrent keloids comparing intralesional cryotherapy with excision combined with brachytherapy This results in a total of 4 study arms; 2 in both parts of the study. Primary endpoint is Patient Observer Scar Assesment Scale (POSAS) score. ;Secondary Objective: Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST, histology,appearance of adverse reactions, and indication for further treatment.;Primary end point(s): POSAS score;Timepoint(s) of evaluation of this end point: before treatment, 2 weeks, 12 weeks, 26 weeks and 52 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST, histology, appearance of adverse reactions and indication for further treatment.;Timepoint(s) of evaluation of this end point: Volume, skindex-29, SF-36, EQ-5D, adverse reactions: Before treatment, 2 weeks, 12 weeks, 26 weeks and 52 weeks after treatment QST, indication for further treatment and Histology: before treatment en 26 weeks after treatment. | — |
Countries
Netherlands
Outcome results
None listed