Status:
COMPLETED
Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
Lead Sponsor:
Cutera Inc.
Conditions:
Poikiloderma of Civatte
Dyschromia
Eligibility:
All Genders
35-65 years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01491620
Start Date
November 1 2011
End Date
May 1 2013
Last Update
October 28 2022
Active Locations (1)
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1
Zel Skin and Laser Specialists
Edina, Minnesota, United States, 55424