Finding an effective and permanent treatment against keloid.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is POSAS score.
Secondary outcome
Secondary endpoints are volume reduction, Skindex-29, SF-36, ED-5Q, QST,
histology, appearance of adverse reactions and indication for further
treatment.
Background summary
When the complex process of dermal healing is disturbed this can result in
excessive scarring. Keloid disease is a tumorous scar that grows outside of
wound borders. It appears as a raised, vascular, pigmented 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. There is a lack of randomized studies
comparing treatments, thereby no hard evidence favoring one treatment over
another exists and many suboptimal treatments are in practice.
Study objective
Finding an effective and permanent treatment against keloid.
Study design
Comparing intralesional cryotherapy for keloid disease with current best
practice treatment on objective and subjective outcome.
We will do this by a randomized controlled intervention study consistent of 2
parts;
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.
Intervention
1) Primary keloids: intralesional cryotherapy or extralesional excision with
adjuvant triamcenolonacetonide 40mg/ml injections starting 2 weeks post
operative.
2) Recurrent keloids: intralesional cryotherapie or extralesional excision with
adjuvant Ir-192 brachytherapy (18Gy in 2 dosis within 8 hours post operative).
Study burden and risks
Patients will receive regular treatments participating in this study; however
they cannot choose which treatment they receive. Burdens associated with the
treatments are similar as when they would have been treated regularly.
Completion of the questionnaires will take an additional 20 to 50 minutes on
intake and all 4 follow-up visits. The questionnaires may contain personal or
confronting questions. We ask patients specially for permission to take a 3mm
biopsy on after treatment for histological measurements. The keloids included
have a minimum size of 1x1 cm and are often much bigger, the biopsy is a small
sample compared to the scar present. Injury can activate keloid.
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
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.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002675-34-NL |
| CCMO | NL40235.078.12 |
| OMON | NL-OMON22731 |