Idiopathic Guttate Hypomelanosis
Conditions
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 description
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.
Interventions
DEVICEExcimer Light Treatment
Excimer light treatment will be performed on one leg of every subject as the intervention while the subjects other leg will serve as a control
Sponsors
American Society of Dermatologic Surgeons
Photomedex
Seton Healthcare Family
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Outcome | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Self-reported Assessment of Re-pigmentation for Treated Lesions | 12 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All Study Participants | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: 12 weeks
Population: healthy adult patients with bilateral IGH lesions on lower extremities
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Excimer Light Treatment | Efficacy Outcome | 2.31 units on a scale |
| Control | Efficacy Outcome | 1.15 units on a scale |
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).
Time frame: 12 weeks
Population: healthy adult patients with bilateral IGH lesions on lower extremities
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excimer Light Treatment | Subject Self-reported Assessment of Re-pigmentation for Treated Lesions | 4.5 units on a scale | Standard Deviation 0.223 |