Clinical trial NCT01491620: Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
Official title: A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poikiloderma of Civatte
Dyschromia
Pigmentation Disorders
Telangiectasia
Photosensitivity Disorders
Keywords: poikiloderma of Civatte
red dyschromia
brown dyschromia
sun damage
neck
chest
dyschromia
pigmentation disorders
erythema
photosensitivity disorders
sun exposure
telangiectasia
hyperpigmentation
hypopigmentation
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Severity Assessment Score
timeFrame: 24 weeks
measure: Physician's Global Assessment (Blinded)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edina
country: United States
facility: Zel Skin and Laser Specialists
state: Minnesota
Study officials:
References: