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

Not Applicable

Completed

• Conditions: Pigmentation Disorders; Photosensitivity Disorders; Dyschromia; Poikiloderma of Civatte; Telangiectasia
• Interventions: Device: 532 nm KTP laser

• Registration Number: NCT01491620
• Lead Sponsor: Cutera Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-14
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2022-10
• Results First Submitted: 2022-10-03
• Results First Submitted QC: 2022-10-03
• Last Update Submitted: 2022-10-03
• Results First Posted: 2022-10-28
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
532 nm KTP laser treatment	532 nm KTP laser	-

Primary Outcome Measures

Name	Time	Method
Physician's Global Assessment (Blinded)	24 weeks	Before and after subject photographs were presented to a panel of independent dermatologists. The panel was blinded to treatment parameters and the photograph time points. Each dermatologist was asked to select the baseline photograph and then rate improvement in Poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale.; Physician's Global Assessment (min= -1; max=4) Higher scores mean better outcome
Severity Assessment Score	24 weeks	Change in Physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists.; Blinded Physician's Severity Assessment (min=1;max=4); Higher scores mean worse values

Trial Locations

Locations (1)

Zel Skin and Laser Specialists; 🇺🇸 Edina, Minnesota, United States