Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study

NCT ID: NCT01956435

Last Updated: 2017-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-10-31

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.

Conditions

Idiopathic Guttate Hypomelanosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Excimer Light Treatment Right Leg, Control Left Leg

Excimer light treatment will be performed on the right leg of every subject, no treatment on the left or control leg of the subject.

Group Type: OTHER

Excimer Light Treatment

Intervention Type: 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

Excimer Light Treatment Left Leg, Control Right Leg

Excimer light treatment will be performed on the left leg of every subject, no treatment on the right or control leg of the subject.

Group Type: OTHER

Excimer Light Treatment

Intervention Type: 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

Interventions

Excimer 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

Intervention Type: DEVICE

Other Intervention Names

Xtrac; Excimer laser; phototherapy

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Society of Dermatologic Surgeons

UNKNOWN

Sponsor Role: collaborator

Photomedex

UNKNOWN

Sponsor Role: collaborator

Seton Healthcare Family

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ammar Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Seton Healthcare Family

Locations

Seton Family of Hospitals- Trinity Clinic

Austin, Texas, United States

Countries

United States

Other Identifiers

CR-13-151

Identifier Type: -

Identifier Source: org_study_id