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

NCT ID: NCT01491620

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

532 nm KTP laser treatment

Group Type: EXPERIMENTAL

532 nm KTP laser

Intervention Type: DEVICE

Laser treatment sessions on the neck and/or chest

Interventions

532 nm KTP laser

Laser treatment sessions on the neck and/or chest

Intervention Type: DEVICE

Other Intervention Names

Excel V

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cutera Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zel Skin and Laser Specialists

Edina, Minnesota, United States

Countries

United States

Other Identifiers

C-11-XPC01

Identifier Type: -

Identifier Source: org_study_id