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

NCT04377828 | Unknown

• 2 other identifiers: RC31/19/05152020-A00421-38
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Mastocytosis

Keywords

Cutaneous mastocytosis; laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Global clinical evolution of the skin M1 - Blind evaluator

  Month 1

• Global clinical evolution of the skin M9 - Blind evaluator

  Month 9

• Global clinical evolution of the skin M4 - Principal investigator

  Month 4

• Global clinical evolution of the skin M1 - Principal investigator

  Month 1

• Global clinical evolution of the skin M9 - Principal investigator

  Month 9

Study Arms (1)

Laser intervention

EXPERIMENTAL

1 to 2 sessions of pigment laser1

Device: Pigment laser

Interventions

Pigment laser DEVICE

one to two session of pigment laser (532 nm)

Laser intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Larrey Hospital - Toulouse University Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Mastocytosis, Cutaneous

Condition Hierarchy (Ancestors)

Mastocytosis; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Mast Cell Activation Disorders; Immune System Diseases

Study Officials

• Christina BULAI LIVIDEANU, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina BULAI LIVIDEANU, MD

CONTACT

(0)5 61 77 81 38; livideanu.c@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 6, 2020
• Study Start: September 14, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)