Idiopathic Guttate HypomelanosisNCT01956435
Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study
A study testing Excimer Light Treatment in people with Idiopathic Guttate Hypomelanosis, run by Seton Healthcare Family at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Guttate Hypomelanosis
- What is being tested?
- Excimer Light Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Seton Family of Hospitals- Trinity Clinic
Austin, Texas, 78701
About this study
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.
Read the 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
- Being tested
- Excimer Light Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excimer Light TreatmentDevice
Also called Xtrac, Excimer laser, phototherapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Excimer Light Treatment |
| 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. Receives: Device: Excimer Light Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Guttate HypomelanosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Dermatologic Surgeons, Photomedex
- Responsible party
- Sponsor
- Investigators
- Ammar Ahmed, MD, Principal investigator, Seton Healthcare Family
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956435
- Sponsor's protocol ID
- CR-13-151
- Status last verified
- Oct 2017
- First submitted
- 27 Sep 2013
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excimer Light Treatment for Idiopathic Guttate Hypomelanosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT01956435
- Acronym / sponsor ID
- CR-13-151
- Conditions
- Idiopathic Guttate Hypomelanosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Collaborators
- American Society of Dermatologic Surgeons, Photomedex
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 18 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excimer Light Treatment Right Leg, Control Left Leg | Other | Device: Excimer Light TreatmentExcimer light treatment will be performed on the right leg of every subject, no treatment on the left or control leg of the subject. |
| Excimer Light Treatment Left Leg, Control Right Leg | Other | Device: Excimer Light TreatmentExcimer light treatment will be performed on the left leg of every subject, no treatment on the right or control leg of the subject. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excimer Light TreatmentAlso: Xtrac, Excimer laser, phototherapyExcimer light treatment will be performed on one leg of every subject as the intervention while the subjects other leg will serve as a control | Device | Excimer Light Treatment Left Leg, Control Right Leg, Excimer Light Treatment Right Leg, Control Left Leg |
Primary outcome
Efficacy Outcome
Time frame: 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.
1 secondary outcome
Subject Self-reported Assessment of Re-pigmentation for Treated Lesions
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammar Ahmed, MD principal investigator
Seton Healthcare Family
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excimer Light Treatment in people with Idiopathic Guttate Hypomelanosis, run by Seton Healthcare Family at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Outcome (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.