Improvement of Pigmented Skin Lesions in Patients With Mastocytosis After Performing 2 Sessions of Pigment Laser (LaserMasto)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Cutaneous Mastocytosis
• Intervention / Treatment: Device: Pigment laser

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina BULAI LIVIDEANU, MD; Phone Number: +33 (0)5 61 77 81 38; Email: livideanu.c@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Larrey Hospital - Toulouse University Hospital
    • Contact: Christina BULAI LIVIDEANU, MD
    • Principal Investigator: Cristina BULAI LIVIDEANU, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser intervention; 1 to 2 sessions of pigment laser1	Device: Pigment laser; one to two session of pigment laser (532 nm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Christina BULAI LIVIDEANU, MD, Toulouse University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: laser; Cutaneous mastocytosis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Hypersensitivity; Neoplasms, Connective Tissue; Immune Complex Diseases; Mastocytosis; Pigmentation Disorders; Mastocytosis, Cutaneous; Mastocytoma
• Other Study ID Numbers: RC31/19/0515; 2020-A00421-38 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No