Clinical trial NCT01956435: Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study
Official title: Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Guttate Hypomelanosis
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
Collaborators: name: American Society of Dermatologic Surgeons
name: Photomedex
First posted: 2013-10-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Efficacy Outcome
timeFrame: 12 weeks
Secondary outcomes:
measure: Subject Self-reported Assessment of Re-pigmentation for Treated Lesions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: Seton Family of Hospitals- Trinity Clinic
state: Texas
Study officials:
affiliation: Seton Healthcare Family
name: Ammar Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: