Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT01491620
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT01491620
Study Brief:
Protocol Section:
NCT01491620