E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Hypertrophic and keloid scars are scars as a result of dermal injury and exhibit exuberant, indefinite growth of collagen during wound healing. They often cause hypersensitivity and pain. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• 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)
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E.2.2 | Secondary objectives of the trial |
• 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.). (
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E.5.1.1 | 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.
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E.5.2 | 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.
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E.5.2.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |