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

Telangiectasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491620
• Other study ID #: C-11-XPC01
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2022
• Source: Cutera Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Dyschromia
• Photosensitivity Disorders
• Pigmentation Disorders
• Poikiloderma of Civatte
• Telangiectasia
• Telangiectasis

Intervention

Device:
• 532 nm KTP laser
Laser treatment sessions on the neck and/or chest

Locations

Country	Name	City	State
United States	Zel Skin and Laser Specialists	Edina	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Cutera Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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