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Excimer laser versus clobetason propionaat in prurigo form of atopic dermatitis.

Excimer laser versus clobetason propionaat in prurigo form of atopic dermatitis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29170
Enrollment
20
Registered
2006-09-19
Start date
2006-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prurigo form of atopic dermatitis

Interventions

All patients will be randomized to a within-patient left-right comparison study of excimer laser versus topical clobetason propionaat. Treatment with the ecximer laser will be performed twice a week,

Sponsors

Academic Medical Center, University of Amsterdam, Dept. of Dermatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients (>18 years old); 2. Prurigo form of atopic dermatitisbased on: 2.1 Hanifin and Rajka criteria fullfilled; 2.2 Presence of allergen specific IgE; 2.3 Lasting for at least 6 months; 2.4 Refractory to the standard therapy; 2.5 At least 4 symmetrical nodules; 3. Upper or lower extremities affected; 4. Written informed consent provided.

Exclusion criteria

Exclusion criteria: 1. Patients unable to comply with the requirements of the study; 2. Female patients who are pregnant or breastfeeding; 3. Patients treated with sedating antihistamines within 24hrs before start of study treatment; 4. Patients treated with topical steroids within one week before start of study treatment; 5. Patients treated with phototherapy or PUVA within one week before start of study treatment; 6. Patients treated with systemic therapy that might have an effect on the prurigo form of AD within 4 weeks before start of study treatment; 7. Patients with hypersensitivity to the study treatment or sunlight; 8. Patients receiving drugs known to cause photosensitivity and/or photo toxicity; 9. Patients with any other interfering skin diseases, which jeopardize the study.

Design outcomes

Primary

MeasureTime frame
Clinical responses will be evaluated using Physician assessment of individual signs (number of nodules, elevation of nodules, excoriation, erythema and pruritus).

Secondary

MeasureTime frame
Photographic documentation, Physician Global assessment (PGA) and Patient Global Assessment (PaGA) will be evaluated. Besides the clinical responses, the patient and physician satisfaction/preference and duration of remission will be evaluated.

Contacts

Public ContactE.E.A. Brenninkmeijer

Academic Medical Center Amsterdam (AMC) Department of Dermatology, A0-223 P.O. Box 22660

E.E.Brenninkmeijer@amc.uva.nl+31(0)20 5662581

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)