Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Guttate Hypomelanosis
• Intervention / Treatment: Device: Excimer Light Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78701
      • Seton Family of Hospitals- Trinity Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Outcome	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Self-reported Assessment of Re-pigmentation for Treated Lesions	Subject reported level of re-pigmentation for treated lesions was assessed by improvement from baseline using a scale from 1 - 4 with 1 being the least amount of re-pigmentation and 4 being the most re-pigmentation: 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).	12 weeks

Collaborators and Investigators

• Sponsor: Seton Healthcare Family
• Collaborators: American Society of Dermatologic Surgeons; Photomedex
• Investigators: Principal Investigator: Ammar Ahmed, MD, Seton Healthcare Family

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 27, 2013
• First Submitted That Met QC Criteria: October 6, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation
• Other Study ID Numbers: CR-13-151