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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.
ClinicalTrials.gov Identifier:
NCT01491620
First received: December 5, 2011
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention
Poikiloderma of Civatte
Dyschromia
Pigmentation Disorders
Telangiectasia
Photosensitivity Disorders
Device: 532 nm KTP laser

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

Resource links provided by NLM:


Further study details as provided by Cutera Inc.:

Primary Outcome Measures:
  • Severity Assessment Score [ Time Frame: 24 weeks post final treatment ] [ Designated as safety issue: No ]
    Change in physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists.

  • Physician's Global Assessment (Blinded) [ Time Frame: 24 weeks post final treatment ] [ Designated as safety issue: No ]
    Before and after subject photographs will be presented to a panel of independent dermatologists. The panel will be blinded to treatment parameters and the photograph time point. Each dermatologist will be 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.


Secondary Outcome Measures:
  • Physician's Global Assessment [ Time Frame: 12 and 24 weeks post final treatment ] [ Designated as safety issue: No ]
    Investigator will assess improvement in poikiloderma of Civatte as compared to baseline using a 5-point improvement scale.

  • Severity Assessment Score [ Time Frame: 12 and 24 weeks post final treatment ] [ Designated as safety issue: No ]
    Investigator will perform Severity Assessment of the subject's poikiloderma of Civatte.

  • Subject's Global Assessment [ Time Frame: 12 and 24 weeks post final treatment ] [ Designated as safety issue: No ]
    Subjects will assess improvement of poikiloderma of Civatte as compared to baseline using a 5-point improvement scale.

  • Subject Satisfaction Assessment [ Time Frame: 12 and 24 weeks post final laser treatment ] [ Designated as safety issue: No ]
    Subjects will assess overall satisfacion with improvement of poikiloderma of Civatte and proceedure using a 5-point satisfaction scale.

  • Spectrophotometer Measurement [ Time Frame: 12 and 24 weeks post final laser treatment ] [ Designated as safety issue: No ]
    Change in pigmentation and erythema as assessed by spectrophotometer measurements as compared to baseline.

  • Assessment of Adverse Events [ Time Frame: 24 weeks post final laster treatment ] [ Designated as safety issue: Yes ]
    Incidence and severity of all procedure-related adverse events.


Enrollment: 24
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 532 nm KTP laser treatment Device: 532 nm KTP laser
Two laser treatment sessions, 6 weeks apart.
Other Name: Excel V

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491620

Locations
United States, Minnesota
Zel Skin and Laser Specialists
Edina, Minnesota, United States, 55424
Sponsors and Collaborators
Cutera Inc.
  More Information

No publications provided

Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT01491620     History of Changes
Other Study ID Numbers: C-11-XPC01
Study First Received: December 5, 2011
Last Updated: August 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cutera Inc.:
poikiloderma of Civatte
red dyschromia
brown dyschromia
sun damage
neck
chest
dyschromia
pigmentation disorders
erythema
photosensitivity disorders
sun exposure
telangiectasia
hyperpigmentation
hypopigmentation

Additional relevant MeSH terms:
Photosensitivity Disorders
Telangiectasis
Pigmentation Disorders
Dermatitis, Phototoxic
Epilepsy, Reflex
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Dermatitis, Irritant
Dermatitis, Contact
Dermatitis
Skin Diseases, Eczematous
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014