search
Back to results

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

Primary Purpose

Poikiloderma of Civatte, Dyschromia, Pigmentation Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
532 nm KTP laser
Sponsored by
Cutera Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Poikiloderma of Civatte focused on measuring poikiloderma of Civatte, red dyschromia, brown dyschromia, sun damage, neck, chest, dyschromia, pigmentation disorders, erythema, photosensitivity disorders, sun exposure, telangiectasia, hyperpigmentation, hypopigmentation

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zel Skin and Laser Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

532 nm KTP laser treatment

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
December 5, 2011
Last Updated
October 3, 2022
Sponsor
Cutera Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01491620
Brief Title
Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
Official Title
A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutera Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
532 nm KTP laser treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
532 nm KTP laser
Other Intervention Name(s)
Excel V
Intervention Description
Laser treatment sessions on the neck and/or chest
Primary Outcome Measure Information:
Title
Severity Assessment Score
Description
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
Time Frame
24 weeks
Title
Physician's Global Assessment (Blinded)
Description
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
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Zel Skin and Laser Specialists
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs