N/A
N=24
Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
Poikiloderma of Civatte · Dyschromia · Pigmentation Disorders · Telangiectasia · Photosensitivity Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01491620 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Severity Assessment Score — -0.06; 0.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 532 nm KTP laser (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Cutera Inc.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity Assessment Score |
-0.06; 0.2 | — |
| PRIMARY Physician's Global Assessment (Blinded) |
.06; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01491620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.