Idiopathic Guttate Hypomelanosis Clinical Trial
Official title:
Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study
| Verified date | October 2017 |
| Source | Seton Healthcare Family |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 6 |
| Est. completion date | October 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Seton Family of Hospitals- Trinity Clinic | Austin | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Seton Healthcare Family | American Society of Dermatologic Surgeons, Photomedex |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |