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.
Conditions
Interventions
Trade Name: Dermovate
Product Name: Dermovate
Product Code: RVG06933
Pharmaceutical Form: Ointment
INN or Proposed INN: CLOBETASOL PROPIONATE
CAS Number: 25122467
Concentration unit: % (W/W) percent w
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: to assess the duration of remissions achieved with excimer laser and to evaluate the patient’s and investigator’s satisfaction/preferences regarding both treatments. ;Primary end point(s): Efficacy of the excimer laser in prurigo form of AD. | — |
Countries
Netherlands
Outcome results
None listed