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Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01956435
First Posted: October 8, 2013
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
American Society of Dermatologic Surgeons
Photomedex
Information provided by (Responsible Party):
Seton Healthcare Family
  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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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 Healthcare Family:

Primary Outcome Measures:
  • Efficacy Outcome [ Time Frame: 12 weeks ]
    Effectiveness will be graded by the blinded observer scal via photographic comparisons at the end of the study. Efficacy was assessed by improvement from baseline using the following scale: -1 = Worsening of IGH; 0 = No Improvement (IGH remained stable); 1 = Mild improvement of IGH (some re-pigmentation on <50% IGH); 2 = Moderate improvement (some re-pigmentation on >50% or full re-pigmentation on <75% IGH); 3 = Full re-pigmentation on >75% IGH.


Secondary Outcome Measures:
  • Subject Self-reported Assessment of Re-pigmentation for Treated Lesions [ Time Frame: 12 weeks ]

    Subject reported level of re-pigmentation for treated lesions was assessed by improvement from baseline using the following scale:

    1 = Worsening of the light spots that were treated (the light spots seem to have gotten lighter or I have more light spots in the areas that were treated); 2 = No Improvement of the light spots (light spots have not changed since starting this study); 3 = Mild improvement of the light spots (there is some darkening of the light spots, but not in more than half of them); 4 = Moderate improvement (there is some darkening of the light spots in more than half of the light spots, but not more than 75% of them).



Enrollment: 6
Study Start Date: March 2014
Study Completion Date: October 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Excimer Light Treatment Right Leg, Control Left Leg
Excimer light treatment will be performed on the right leg of every subject, no treatment on the left or control leg of the subject.
Device: Excimer Light Treatment
Excimer light treatment will be performed on one leg of every subject as the intervention while the subjects other leg will serve as a control
Other Names:
  • Xtrac
  • Excimer laser
  • phototherapy
Excimer Light Treatment Left Leg, Control Right Leg
Excimer light treatment will be performed on the left leg of every subject, no treatment on the right or control leg of the subject.
Device: Excimer Light Treatment
Excimer light treatment will be performed on one leg of every subject as the intervention while the subjects other leg will serve as a control
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 Dr. Jennifer Gordon or Dr. Ammar Ahmed 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956435


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

Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT01956435     History of Changes
Other Study ID Numbers: CR-13-151
First Submitted: September 27, 2013
First Posted: October 8, 2013
Results First Submitted: February 7, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Hypopigmentation
Pigmentation Disorders
Skin Diseases