Trial record 2 of 32 for:    Open Studies | "Hypopigmentation"

Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Seton Family of Hospitals
Sponsor:
Collaborators:
American Society of Dermatologic Surgeons
Photomedex
Information provided by (Responsible Party):
Seton Family of Hospitals
ClinicalTrials.gov Identifier:
NCT01956435
First received: September 27, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

This pilot study will consist of 10 adult subjects with symmetric idiopathic guttate hypomelanosis on the lower legs. Subjects will be randomized to which extremity (right or left) will be treated. Treatments with the Xtrac Excimer laser will be performed twice weekly for 12 weeks using the typical vitiligo protocol. Our goal is to determine the effectiveness of excimer laser for repigmentation of idiopathic guttate hypomelanosis. Effectiveness will be graded by the blinded observer scale via photographic comparisons and will be graded by subject via survey every 4 weeks.


Condition Intervention
Idiopathic Guttate Hypomelanosis
Device: Excimer Light Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Seton Family of Hospitals:

Primary Outcome Measures:
  • Efficacy Outcome [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine the effectiveness of excimer laser treatment for repigmentation of idiopathic guttate hypomelanosis. Effectiveness will be graded by the blinded observer scale via photographic comparisons at the end of the study


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine subject reported effectiveness of excimer laser for repigmentation of idiopathic guttate hypomelanosis. Effectiveness will be graded by subject via survey every 4 weeks


Estimated Enrollment: 20
Study Start Date: March 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Excimer Light Treatment
Excimer light treatment will be performed on the randomized leg of every subject
Device: Excimer Light Treatment
Excimer light treatment will be performed on one leg of every subject as the intervention
Other Names:
  • Xtrac
  • Excimer laser
  • phototherapy

Detailed Description:

Methods: This pilot study will consist of 10 adult subjects with symmetric IGH on the lower legs. After enrollment, 5 lesions of IGH on each leg will be selected by either JG or AA and marked. Subjects will be randomized to which extremity (right or left) will be treated. Treatments with the Xtrac Excimer laser (wavelength of 308nm) will be performed twice weekly for 12 weeks using the typical vitiligo protocol (see Appendix C). Photographs of both extremities will be taken prior to initial treatment and then every 4 weeks. The photographs will be analyzed by two separate, blinded dermatologists and rated on improvement from baseline using the following scale: 1= worsening of IGH; 2= no improvement (IGH remained stable); 3= mild improvement of IGH (some repigmentation on <50% IGH); 4= moderate improvement (some repigmentation on >50% or full repigmentation on <75% IGH); 5= full repigmentation on >75% IGH (see Appendix A). Subjects will also be asked to complete this survey subjectively every 4 weeks. Internal control will be represented by the marked lesions on the non-treated extremity of each patient. Control versus treatment groups will be statistically compared; however, due to the limited number of patient in this pilot study, a descriptive trend analysis will likely be completed. Subjects will be compensated $10 per visit (totaling $250). If a subject withdraws early from the study, they will be compensated for every completed visit. The 25th visit will consist of final photographs and surveys, and will not include treatment.

Statistical Analysis: The main outcomes to be collected are the improvement of IGH from baseline at weeks 4, 8 and 12 by the blinded dermatologists and by the subjects. Subjects will be stratified by Fitzpatrick skin type for analysis as well.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Diagnosis of idiopathic guttate hypomelanosis on the bilateral lower extremities with at least 5 lesions on each leg that are overall symmetric as determined by study personnel
  • Patients must be 18 years or older
  • Patients may be from any ethnicity but are required to be English-speakers
  • Patients must provide written informed consent to participate in the study

Exclusion Criteria

  • Patients with pre-existing dermatological condition that is exacerbated by ultraviolet radiation
  • Non-English speakers
  • Patients taking medications known to have potential phototoxic reactions
  • Use of Ultraviolet tanning beds, Ultraviolet-A, Ultraviolet- B or excimer therapy within the previous 3 months on the lower extremities
  • Current or previous treatment within the past 3 months specifically for IGH
  • Pregnancy or pregnancy within the past 3 months (this can cause changes in pigmentation)
  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: NCT01956435

Contacts
Contact: Poppy E Poth, BS 512-324-1000 ext 89612 pepoth@seton.org

Locations
United States, Texas
Seton Family of Hospitals- Trinity and Hays Clinic
Austin, Texas, United States, 78701
Sponsors and Collaborators
Seton Family of Hospitals
American Society of Dermatologic Surgeons
Photomedex
Investigators
Principal Investigator: Jennifer R Gordon, MD Seton Family of Hospitals
  More Information

No publications provided

Responsible Party: Seton Family of Hospitals
ClinicalTrials.gov Identifier: NCT01956435     History of Changes
Other Study ID Numbers: CR-13-151
Study First Received: September 27, 2013
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014