N/A
N=6
Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study
Idiopathic Guttate Hypomelanosis
Bottom Line
View on ClinicalTrials.gov: NCT01956435 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Efficacy Outcome — 2.31; 1.15 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Excimer Light Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seton Healthcare Family
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Outcome |
2.31; 1.15 | — |
| SECONDARY Subject Self-reported Assessment of Re-pigmentation for Treated Lesions |
4.5 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01956435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.