Clinical Trial: Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Seton Healthcare Family

Current Primary Outcome: Efficacy Outcome [ Time Frame: 12 weeks ]

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


Original Primary Outcome: Efficacy Outcome [ Time Frame: 12 weeks ]

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 at the end of the study


Current Secondary Outcome: Efficacy [ Time Frame: 12 weeks ]

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


Original Secondary Outcome: Same as current

Information By: Seton Healthcare Family

Dates:
Date Received: September 27, 2013
Date Started: March 2014
Date Completion:
Last Updated: April 18, 2016
Last Verified: April 2016