Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).

Official Title
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A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

Conditions
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Poikiloderma of Civatte, Dyschromia, Pigmentation Disorders, Telangiectasia, Photosensitivity Disorders

Intervention / Treatment
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* Device: 532 nm KTP laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fitzpatrick Skin Type I - III Clinical diagnosis of poikiloderma of Civatte affecting the neck and/or chest Willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area Agree not to undergo any other procedure for the treatment of poikiloderma of Civatte during the study Willing and able to read, understand and sign the Informed Consent Form Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions Exclusion Criteria: Any laser treatment on neck and/or chest within 12 months Any topical treatment on neck and/or chest within 6 months Pregnant and/or breastfeeding Infection, dermatitis or a rash in the treatment area Suffering from significant concurrent illness, such as Diabetes Mellitus or pertinent neurological disorders History of seizure disorders due to light, fibromyalgia, connective tissue disease, vitiligo, psoriasis, pigmentary disorders, keloid scarring, hypertrophic scarring or abnormal wound healing History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications Having a known anticoagulative condition or taking anticoagulation medications History of diseases stimulated by heat, unless treatment is conducted following a prophylactic regimen Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely) History of radiation to the head, neck and/or upper chest Undergoing systemic chemotherapy for the treatment of cancer Systemic use of isotretinoin (Accutane®) within 6 months Any use of gold therapy Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study Current smoker or history of smoking within 12 months of study Participation in a study of another device or drug within 6 months As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 532 nm KTP laser treatment<br> | Device: 532 nm KTP laser<br>* Laser treatment sessions on the neck and/or chest<br>* Other names: Excel V;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity Assessment Score | Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists. Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values | 24 weeks | 
| Physician's Global Assessment (Blinded) | Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale. Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poikiloderma of Civatte, red dyschromia, brown dyschromia, sun damage, neck, chest, dyschromia, pigmentation disorders, erythema, photosensitivity disorders, sun exposure, telangiectasia, hyperpigmentation, hypopigmentation