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

Cutera

Status

Completed

Conditions

Poikiloderma of Civatte

Dyschromia

Telangiectasia

Pigmentation Disorders

Photosensitivity Disorders

Treatments

Device: 532 nm KTP laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT01491620

C-11-XPC01

Details and patient eligibility

About

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).

Enrollment

24 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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