E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
the excimer laser appears to be a promising treatment for localized atopic dermatitis. Therefore we designed a randomized trial to investigate the efficacy of this excimer laser versus topical clobetasol propionaat in patients with the prurigo form of atopic dermatitis.
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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 |
to investigate the efficacy of XeCl excimer laser therapy versus topical corticosteroid in a side-to-side comparison in patients with the prurigo form of AD. |
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E.2.2 | Secondary objectives of the trial |
to assess the duration of remissions achieved with excimer laser and to evaluate the patient’s and investigator’s satisfaction/preferences regarding both treatments. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosis of the prurigo form of AD is based on : o Hanifin and Rajka Diagnostic Criteria(10) o Presence of allergen specific IgE(9) o Prurigo nodules Therapy resistant prurigo lesions, > 6 months, without spontaneous remission At least 4 symmetrical prurigo lesions/nodules, on lower or upper extremities Written informed consent
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E.4 | Principal exclusion criteria |
Treatment with systemic therapy that might have an effect on the prurigo form of AD (e.g. corticosteroids, retinoids, immunosuppressants) within 4 weeks before start of study treatment Treatment with sedating antihistamines (e.g. Polaramine, Fenistil, Atarax, Zaditen, Nedeltran, Phenergan) within 24hrs before start of study treatment Treatment with topical corticosteroids within one week before start of study treatment Treatment with phototherapy or PUVA within one week before start of study treatment Hypersensitivity to the study medication or sunlight Treatments known to cause photosensitivity and/or photo toxicity (eg. tetracycline, retinoids, sulfonamids, psoralens, NSAID’s) Patients who are pregnant or breast-feeding Patients with any other interfering skin diseases, which jeopardize the study Patients unable to comply with the requirements of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy of the excimer laser in prurigo form of AD. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
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.8.3 |
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 | Information not present in EudraCT |
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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by a within-patient randomized controlled trial, up to 20 patients will be included to investigate the efficacy of the ecximer laser versus clobetasol propionaat in prurigo form of atopic dermatitis. patients will be treated for 10 weeks plus a folluw-up six months. The inclusion period will be one or two months. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |