Hypertrophic and keloid scars are pathological scars as a result of dermal injury and exhibit exuberant, indefinite growth of collagen during wound healing. Hypertrophic and keloid scars often cause symptoms such as hypersensitivity, pruritus or pain. Patients are often affected with major cosmetic, psychological and social consequesnce.
Conditions
Interventions
Trade Name: Verapamil Hydrochloride
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Verapamil
CAS Number: 99300-78-4
Other descriptive name: VERAPAMIL HYDROCHLORIDE
Concentration un
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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://medical dictionary.thefreedictionary.com/keloid) ? = 18 years old 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 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ? Allergy or intolerance to corticosteroids or Verapamil ? Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Scar volume To objectively determine and compare the efficacy of Verapamil, Kenacort+Verapamil, and Kenacort injections. Using the Vectra XT 3D imaging system (Canfield Imaging Systems, Fairfield, NJ) ;Secondary Objective: • Patient and Observer Scar Assessment Scale (POSAS) To subjectively determine and compare the efficacy of Verapamil, Kenacort+Verapamil, and Kenacort injections. Using the POSAS form • Complications/Side effects To determine and compare complications/side effects of Verapamil, Kenacort-Verapamil, and Kenacort injections. ;Primary end point(s): The main study endpoint is difference in volume of the hypertrophic or keloid scar. Volume will be measured by a three-dimensional volume measurement technique using the Vectra XT 3D imaging system (Canfield Imaging Systems, Fairfield, N.J.). The camera determines points in three dimensions by triangulating position of six colour digital cameras. A three-dimensional surface image is generated through the principle of passive stereo photogrammetry, where the texture of the skin is used to determine geometry. Volume measurement will be done using Mirror Analysis 3D software (Canfield Imaging Systems, Fairfield, N.J.). ( ;Timepoint(s) of evaluation of this end point: Objective assessment will be done by using a validated three-dimensional measurement technique. Measurements will be carried out on all 7 appointments. These follow-up moments will take place on week 0, week 1, week 3, week 6, week 13, week 26 and week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The first secondary study endpoint is difference in POSAS score. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically in a 10-point scale and make up a ‘Total Score’ of the Patient and Observer Scale. Observers rate vascularity, pigmentation, pliability, thickness, relief and surface area. The Patient Scale contains six questions applying to pain, itching, colour, pliability, thickness and relief. (See Appendix 2) The other secondary study endpoint is the occurrence of any complications/side effects. Known side effects for intralesional corticosteroids are atrophy, pain and changes in pigmentation.22 Side-effects for intralesional verapamil were not specified by previous studies. ;Timepoint(s) of evaluation of this end point: Subjective assessment will be done by filling out the validated Patient and Observer Scar Assessment Scale. measurements will be carried out on all 7 appointments. These follow-up moments will take place on week 0, week 1, week 3, week 6, week 13, week 26 and week 52. | — |
Countries
Netherlands
Outcome results
None listed