Clinical trial · Interventional
Efficacy and Safety of TF002 in Cutaneous Mastocytosis
NCT00457288CI-TRIAL-00000963completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Mastocytosis | Cutaneous Mastocytosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TF 002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical evaluation of treatment response
Secondary outcomes (2)
- measure
- Number of skin mast cells
- measure
- Volumetric and thermographic analyses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.