Clinical trial · Interventional
Improvement of Pigmented Skin Lesions in Patients With Mastocytosis After Performing 2 Sessions of Pigment Laser
Evaluation of the Improvement of Pigmented Skin Lesions in Patients With Mastocytosis After Performing 2 Sessions of Pigment Laser : Pilot Study Conducted at a Reference Centre Mastocytoses (LaserMasto)
- 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)
Cutaneous mastocytosis can be isolated or associated with systemic involvement. Urticaria pigmentosa affects around 80 to 85% of adult patients with cutaneous mastocytosis. It is also frequently present in patients with mastocytosis associated with systemic involvement (80% of patients in our experience). This skin damage is one of the causes of deterioration in quality of life in patients with mastocytosis, through the loss of self-esteem, due to the appearance of lesions. However there are not treatment for urticaria pigmentosa. Skin involvement in mastocytosis is linked to the accumulation of abnormal mast cells in the dermis. However, the mast cells are not pigmented and the brown-brown color characteristic of Urticaria pigmentosa is explained by melanin pigmentation of the epidermal basal layer.
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 |
|---|---|---|---|
| Pigment laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laser intervention
- description
- 1 to 2 sessions of pigment laser1
- interventionNames
- Device: Pigment laser
Primary outcomes (1)
- measure
- Global clinical evolution of the skin M4 - Blind evaluator
- timeFrame
- Month 4
- description
- Global clinical evolution with IGA " Improvement Global Assessment" (scale with 5 points : no improvement or aggravation/minimal improvement/moderate improvement/significant improvement/complete disappearance) by blind evaluator in month 4 versus baseline
Secondary outcomes (16)
- measure
- Global clinical evolution of the skin M1 - Blind evaluator
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with mastocytosis (diagnosis confirmed clinically according to international criteria) * Patient with pigmented skin lesions, of moderate to very severe severity (by comparison with a 4-point photographic scale: light, moderate, severe and very severe) * Major patient aged ≥ 18 years. * Patient with social security coverage * Patient having given written, free and informed consent to participate in the study Exclusion Criteria: * Patients with mastocytosis, without skin lesions * Patient with pigmented skin lesions, only of mild severity (by comparison with a 4-point photographic scale: mild, moderate, severe and very severe) * Patient with another cutaneous mastocytosis phenotype * Patient treated by a treatment known as a cytoreductive for mastocytosis: alpha interferon, cladribine, imatinib, midostaurin or any cytoreductive treatment being evaluated by clinical trial in mastocytosis * Patient under guardianship, or under curatorship, or not fluent in the French language or unable to understand and complete the study questionnaires * pregnant or breastfeeding women * Patients with tanned skin following photoexposure within 3 weeks of starting the study
References
Publications (0)
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