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

A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

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).

Study Overview

• Status: Completed
• Conditions: Pigmentation Disorders; Photosensitivity Disorders; Telangiectasia; Dyschromia; Poikiloderma of Civatte
• Intervention / Treatment: Device: 532 nm KTP laser

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin and Laser Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 532 nm KTP laser treatment	Device: 532 nm KTP laser; Laser treatment sessions on the neck and/or chest; Other Names: Excel V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity Assessment Score	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	24 weeks
Physician's Global Assessment (Blinded)	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	24 weeks

Collaborators and Investigators

• Sponsor: Cutera Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 5, 2011
• First Submitted That Met QC Criteria: December 13, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: neck; hyperpigmentation; erythema; chest; poikiloderma of Civatte; red dyschromia; brown dyschromia; sun damage; dyschromia; pigmentation disorders; photosensitivity disorders; sun exposure; telangiectasia; hypopigmentation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Disease; Telangiectasis; Photosensitivity Disorders; Pigmentation Disorders
• Other Study ID Numbers: C-11-XPC01