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| Name | Class |
|---|---|
| American Society of Dermatologic Surgeons | UNKNOWN |
| Photomedex | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Excimer Light Treatment Right Leg, Control Left Leg | Other | Excimer light treatment will be performed on the right leg of every subject, no treatment on the left or control leg of the subject. |
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| Excimer Light Treatment Left Leg, Control Right Leg | Other | Excimer light treatment will be performed on the left leg of every subject, no treatment on the right or control leg of the subject. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excimer Light Treatment | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ammar Ahmed, MD | Seton Healthcare Family | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seton Family of Hospitals- Trinity Clinic | Austin | Texas | 78701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Excimer Light Treatment Right Leg, Control Left Leg | Excimer light treatment will be performed on patients randomized to receive treatment on the right leg and left leg will be untreated control |
| FG001 | Excimer Light Treatment Left Leg, Control Right Leg | Excimer light treatment will be performed on patients randomized to receive treatment on the left leg and right leg will be untreated control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This pilot study included six patients with idiopathic guttate hypomelanosis on their lower extremities, which were recruited from an outpatient dermatology clinic.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | healthy adult patients with bilateral IGH lesions on lower extremities | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
12 weeks
XTRAC excimer laser (wavelength of 308 nm) was performed using the standard vitiligo protocol of twice weekly treatments for twelve weeks. Standard safety vitiligo protocols were followed; for instance, if burning occurred, fluence was adjusted appropriately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Excimer Light Treatment | Lesions treated with excimer light | 0 |
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Limitations included a small sample size with minimal variation in Fitzpatrick skin type, an all-female pool, and lack of extended follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ammar Ahmed, MD | University of Texas at Austin Medical School and Seton Family of Hospitals | 512-504-0855 | amahmed@seton.org |
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| ID | Term |
|---|---|
| D054018 | Lasers, Excimer |
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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|
| 12 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Lesions not treated with excimer light |
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| 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). | healthy adult patients with bilateral IGH lesions on lower extremities | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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|
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| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Control | Lesions not treated with excimer light | 0 | 6 | 0 | 6 | 0 | 6 |
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| D013812 |
| Therapeutics |