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

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ClinicalTrials.gov Identifier: NCT01491620
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

December 5, 2011
December 14, 2011
August 7, 2013
November 2011
May 2013   (Final data collection date for primary outcome measure)
  • Severity Assessment Score [ Time Frame: 24 weeks post final treatment ]
    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 ]
    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.
Same as current
Complete list of historical versions of study NCT01491620 on ClinicalTrials.gov Archive Site
  • Physician's Global Assessment [ Time Frame: 12 and 24 weeks post final treatment ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Incidence and severity of all procedure-related adverse events.
Same as current
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Poikiloderma of Civatte
  • Dyschromia
  • Pigmentation Disorders
  • Telangiectasia
  • Photosensitivity Disorders
Device: 532 nm KTP laser
Two laser treatment sessions, 6 weeks apart.
Other Name: Excel V
Experimental: 532 nm KTP laser treatment
Intervention: Device: 532 nm KTP laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
30
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01491620
C-11-XPC01
No
Not Provided
Not Provided
Cutera Inc.
Cutera Inc.
Not Provided
Not Provided
Cutera Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP