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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00421-38 | Other Identifier | ID-RCB |
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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.
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 very 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 is not a 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 pigmentary urticaria is explained by melanin pigmentation of the epidermal basal layer. This characteristic is often described on skin biopsies of pigmentary urticaria analyzed in hematoxilin-eosin.
The 532 nm Q-Switched laser is known to improve lesions characterized by the presence of melanin pigment in the basal layer of the epidermis, with very little risks. This later is explained by the reduced penetration of light at 532 nm into the skin and the emission time of the laser light which is very low (of the order of a few nanoseconds) for Q-Switched lasers. In the literature, 2 case reports report an efficiency of the laser at 532 nm in this indication in adults.
The hypothesis of this study is that 2 sessions of Q-switched laser could improve the skin lesions of urticaria pigmentosa, leading to an improvement in self-esteem.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser intervention | Experimental | 1 to 2 sessions of pigment laser1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pigment laser | Device | one to two session of pigment laser (532 nm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global clinical evolution of the skin M4 - Blind evaluator | 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 | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Global clinical evolution of the skin M1 - Blind evaluator | 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 1 versus baseline | Month 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina BULAI LIVIDEANU, MD | Contact | (0)5 61 77 81 38 | +33 | livideanu.c@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christina BULAI LIVIDEANU, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Larrey Hospital - Toulouse University Hospital | Recruiting | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D034701 | Mastocytosis, Cutaneous |
| ID | Term |
|---|---|
| D008415 | Mastocytosis |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| Global clinical evolution of the skin M9 - Blind evaluator |
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 9 versus baseline |
| Month 9 |
| Global clinical evolution of the skin M4 - Principal investigator | 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 the principal investigator in month 4 versus baseline | Month 4 |
| Global clinical evolution of the skin M1 - Principal investigator | 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 the principal investigator in month 1 versus baseline | Month 1 |
| Global clinical evolution of the skin M9 - Principal investigator | 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 the principal investigator in month 9 versus baseline | Month 9 |
| Severity of a targeted pigment skin lesion - M1 | the surface area of the target pigment skin lesion (mm2) versus baseline | Month 1 |
| Severity of a targeted pigment skin lesion - M4 | the surface area of the target pigment skin lesion (mm2) versus baseline | Month 4 |
| Severity of a targeted pigment skin lesion - M9 | the surface area of the target pigment skin lesion (mm2) versus baseline | Month 9 |
| Psychological impact - baseline | qualitative analysis of the patient verbatim after an interview | Baseline |
| Psychological impact - Month 4 | qualitative analysis of the patient verbatim after an interview | Month 4 |
| Psychological impact - Month 9 | qualitative analysis of the patient verbatim after an interview | Month 9 |
| Patient satisfaction - Month 1 | 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 patient versus baseline | month 1 |
| Patient satisfaction - Month 4 | 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 patient versus baseline | month 4 |
| Patient satisfaction - Month 9 | 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 patient versus baseline | month 9 |
| global patient satisfaction | Analog visual scale from 0 to 10 | month 9 |
| Pigment laser tolerance | Analog visual scale from 0 to 10 | Day 1 |
| D009369 | Neoplasms |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000090362 | Mast Cell Activation Disorders |
| D007154 | Immune System Diseases |