Study of the 532 nm KTP Laser for the T… | Clinical Trial

Key information

Conditions

Poikiloderma of Civatte Cardiovascular Diseases Dyschromia Erythema Hyperpigmentation Hypopigmentation Pathologic Processes Pathological Conditions, Signs and Symptoms Photosensitivity Disorders Pigmentation Disorders Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Telangiectasia Telangiectasis Vascular Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zel Skin and Laser Specialists

Edina, Minnesota, 55424, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

532 nm KTP laser

Device

Laser treatment sessions on the neck and/or chest

Other names: Excel V

Primary outcomes

Severity Assessment Score

Time frame: 24 weeks

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
Physician's Global Assessment (Blinded)

Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

Cutera Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Dec 14, 2011
Registry last updated: Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed