Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/3/2017 |
Start Date: | March 2014 |
End Date: | October 2015 |
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.
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.
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.
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)
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