Idiopathic Guttate Hypomelanosis Clinical Trial
Official title:
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.
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.
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