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

Primary Purpose

Cutaneous Mastocytosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pigment laser
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Mastocytosis focused on measuring Cutaneous mastocytosis, laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Larrey Hospital - Toulouse University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser intervention

Arm Description

1 to 2 sessions of pigment laser1

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
Severity of a targeted pigment skin lesion - M1
the surface area of the target pigment skin lesion (mm2) versus baseline
Severity of a targeted pigment skin lesion - M4
the surface area of the target pigment skin lesion (mm2) versus baseline
Severity of a targeted pigment skin lesion - M9
the surface area of the target pigment skin lesion (mm2) versus baseline
Psychological impact - baseline
qualitative analysis of the patient verbatim after an interview
Psychological impact - Month 4
qualitative analysis of the patient verbatim after an interview
Psychological impact - Month 9
qualitative analysis of the patient verbatim after an interview
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
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
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
global patient satisfaction
Analog visual scale from 0 to 10
Pigment laser tolerance
Analog visual scale from 0 to 10

Full Information

First Posted
April 28, 2020
Last Updated
September 23, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04377828
Brief Title
Improvement of Pigmented Skin Lesions in Patients With Mastocytosis After Performing 2 Sessions of Pigment Laser
Acronym
LaserMasto
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Mastocytosis
Keywords
Cutaneous mastocytosis, laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser intervention
Arm Type
Experimental
Arm Description
1 to 2 sessions of pigment laser1
Intervention Type
Device
Intervention Name(s)
Pigment laser
Intervention Description
one to two session of pigment laser (532 nm)
Primary Outcome Measure Information:
Title
Global clinical evolution of the skin M4 - Blind evaluator
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
Time Frame
Month 4
Secondary Outcome Measure Information:
Title
Global clinical evolution of the skin M1 - Blind evaluator
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 1 versus baseline
Time Frame
Month 1
Title
Global clinical evolution of the skin M9 - Blind evaluator
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 9 versus baseline
Time Frame
Month 9
Title
Global clinical evolution of the skin M4 - Principal investigator
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 the principal investigator in month 4 versus baseline
Time Frame
Month 4
Title
Global clinical evolution of the skin M1 - Principal investigator
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 the principal investigator in month 1 versus baseline
Time Frame
Month 1
Title
Global clinical evolution of the skin M9 - Principal investigator
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 the principal investigator in month 9 versus baseline
Time Frame
Month 9
Title
Severity of a targeted pigment skin lesion - M1
Description
the surface area of the target pigment skin lesion (mm2) versus baseline
Time Frame
Month 1
Title
Severity of a targeted pigment skin lesion - M4
Description
the surface area of the target pigment skin lesion (mm2) versus baseline
Time Frame
Month 4
Title
Severity of a targeted pigment skin lesion - M9
Description
the surface area of the target pigment skin lesion (mm2) versus baseline
Time Frame
Month 9
Title
Psychological impact - baseline
Description
qualitative analysis of the patient verbatim after an interview
Time Frame
Baseline
Title
Psychological impact - Month 4
Description
qualitative analysis of the patient verbatim after an interview
Time Frame
Month 4
Title
Psychological impact - Month 9
Description
qualitative analysis of the patient verbatim after an interview
Time Frame
Month 9
Title
Patient satisfaction - Month 1
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 patient versus baseline
Time Frame
month 1
Title
Patient satisfaction - 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 patient versus baseline
Time Frame
month 4
Title
Patient satisfaction - Month 9
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 patient versus baseline
Time Frame
month 9
Title
global patient satisfaction
Description
Analog visual scale from 0 to 10
Time Frame
month 9
Title
Pigment laser tolerance
Description
Analog visual scale from 0 to 10
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina BULAI LIVIDEANU, MD
Phone
(0)5 61 77 81 38
Ext
+33
Email
livideanu.c@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina BULAI LIVIDEANU, MD
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Larrey Hospital - Toulouse University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina BULAI LIVIDEANU, MD
First Name & Middle Initial & Last Name & Degree
Cristina BULAI LIVIDEANU, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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