Scar volume and POSAS score will be measured in the Verapamil group, these will be compared to the scar volume and POSAS score in the Kenacort+Verapamil group and the Kenacort group. In addition, complications/ adverse effects will be reported.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the difference in volume of the hypertrophic or
keloid scar, measured by a three-dimensional volume measurement technique using
the Vectra XT 3D imaging system. (Canfield Imaging Systems, Fairfield, N.J.)
Secondary outcome
The first secondary study endpoint is difference in POSAS score. The POSAS
consists of two parts: a Patient Scale and an Observer Scale. The other
secondary study endpoint is the occurrence of any complications/side effects.
Background summary
Hypertrophic and keloid scars often lead to major cosmetic and functional
consequences. For this reason, effective treatment is important in clinical
practice. Corticosteroid injections are the mainstay of treatment for excessive
scarring.
Verapamil injections were recently introduced and showed promising results. Our
hypothesis is that Verapamil has a similar efficacy and fewer adverse effects
compared to corticosteroids.
Study objective
Scar volume and POSAS score will be measured in the Verapamil group, these will
be compared to the scar volume and POSAS score in the Kenacort+Verapamil group
and the Kenacort group. In addition, complications/ adverse effects will be
reported.
Study design
A randomized, controlled pilot study with a follow up period of one year will
be performed. Patients will be allocated to one of three groups: Verapamil,
Kenacort+Verapamil, Kenacort. Observers of the volume and POSAS and patients
will be blinded.
Intervention
Patients will receive a series of 3 injections of the medication that they are
allocated to. These injections will be given at the beginning of the study
(week 0), week 1 and week 3.
Study burden and risks
After the series of injections, patients need to visit the outpatient clinic 4
times for the assessments and possible additional treatment. This means a total
of 7 appointments in 1 year. A visit will not take more than 15 minutes; they
have to fill out a questionnaire and a 3D photo will be taken. The close follow
up regarding objective and subjective outcome of treatment in the studied
subjects is likely to be beneficial.
There won*t be any major risks attached to participation. Kenacort is widely
accepted and used for treatment of hypertrophic and keloid scars. Verapamil is
used in daily practice in the Maastricht University Medical Center, with good
experiences so far.
Aalmoezenier Verheggenplein 53
Maastricht 6221 TD
NL
Aalmoezenier Verheggenplein 53
Maastricht 6221 TD
NL
Listed location countries
Age
Inclusion criteria
- Hypertrophic scar
Definition: Excessive overgrowth of dense collagen tissue, often red, pink, or purple in appearance, at the site of a healed skin defect. It resembles a keloid but is usually
temporary, most often regresses without treatment, and remains confined to the site of injury.( http://medical-dictionary.thefreedictionary.com/hypertrophic+scarring)
- Keloid scar
Definition: A nodular, firm, often linear mass of hypertrophic thickish scar tissue,
consisting of irregularly distributed bands of collagen; occurs in the dermis, usually
after trauma, surgery, burn, or a severe cutaneous disease. (http://medicaldictionary.thefreedictionary.com/keloid)
- >= 18 years old
Exclusion criteria
- Hypertrophic or keloid scar on ear and scalp
- Hypertrophic or keloid scar with a treatment history of radio-, brachy- or cryotherapy, or steroid- or other intralesional therapies in the passed year
- Allergy or intolerance to corticosteroids or Verapamil
- Pregnancy
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-003216-37-NL |
| CCMO | NL50902.068.14 |