Efficacy and Safety of TF002 in Cutaneous Mastocytosis

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study will investigate the effects of TF002 on cutaneous mastocytosis or cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate (positive control) and a general skin care product without active ingredient targeting mastocytosis (negative control) based on clinical effects on Darier´s signs and the histological evaluation of mast cell numbers in skin bioptic material.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JADO Technologies GmbH

Criteria

Inclusion Criteria:

• Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier's Sign

• 3 comparable skin lesional areas

• Otherwise healthy according to physical examination

• Informed consent signed and dated

Exclusion Criteria:

• Aggressive systemic mastocytosis

• Other dermatological diseases at treated skin site

• Known hypersensitivity to study drugs or their components

• Mental disorders

• Drug or alcohol dependency

• Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator's decision).

• Immunodeficiency including HIV

• Pregnancy or lactation

• Participation in another clinical trial within the last 30 days

• Malignant skin lesions

• Radiation therapy of target areas excluding UV therapy longer then 4 weeks before start of study treatment

• Dermal comorbidities within the target areas

• Any concomitant medication which might influence the study objectives or are known to provoke or aggravate mastocytosis