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

NCT01491620 | Completed Results

• 1 other identifier: C-11-XPC01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Poikiloderma of Civatte; Dyschromia; Pigmentation Disorders; Telangiectasia; Photosensitivity Disorders

Keywords

poikiloderma of Civatte; red dyschromia; brown dyschromia; sun damage; neck; chest; dyschromia; pigmentation disorders; erythema; photosensitivity disorders; sun exposure; telangiectasia; hyperpigmentation; hypopigmentation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

532 nm KTP laser treatment

EXPERIMENTAL

Device: 532 nm KTP laser

Interventions

532 nm KTP laser DEVICE

Laser treatment sessions on the neck and/or chest

Also known as: Excel V

532 nm KTP laser treatment

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (1)

Zel Skin and Laser Specialists

Edina, Minnesota, 55424, United States

Location

MeSH Terms

Conditions

Pigmentation Disorders; Telangiectasis; Photosensitivity Disorders; Erythema; Hyperpigmentation; Hypopigmentation

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Margot Doucette
• Organization: Cutera

mdoucette@cutera.com

415-657-5518

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 14, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 28, 2022
• Results First Posted: October 28, 2022

Record last verified: 2022-10

Locations

US (1)