VitiligoNCT01259986
Treatment of Vitiligo With Low-energy Visible Light Laser
A study testing Laser treatment in people with Vitiligo, run by Henry Ford Health System.
Trial summary
The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible light laser in the treatment of various recalcitrant forms of vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old
- Have active or stable segmental vitiligo on the neck or face, acral vitiligo, or have undergone recent melanocyte-keratinocyte transplantation procedure (MKTP)
- Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures
Who cannot join
- Women who are lactating, pregnant, or planning to become pregnant
- Patients with a recent history of melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
- Patients with a known history of photosensitivity disorders
- Photosensitizing medications may be continued throughout of the study at the discretion of the investigator
- Patients with a known history of melanoma or non-melanoma skin cancers
- Concomitant use of tanning beds
- Any reason the investigator feels the patient should not participate in the study
About this study
Official title: Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser
The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible light laser in the treatment of various recalcitrant forms of vitiligo.
Read the detailed description
Vitiligo is a pigmentary disorder characterized by depigmented and hypopigmented macules and patches. There are forms of vitiligo which are more resistant to treatment, including segmental vitiligo and acral vitiligo. Previous studies have shown that a low energy helium-neon (633 nm) laser can cause increased proliferation of melanocytes and repigmentation in segmental-type vitiligo. The goal of this study is to verify these results and show efficacy in other recalcitrant forms of vitiligo including acral vitiligo and post melanocyte-keratinocyte transplantation vitiligo.
- Conditions
- Vitiligo
- Being tested
- Laser treatment
- Keywords
- Vitiligo, Laser, Segmental vitiligo, Acral vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentProcedure or surgery
Laser treatment of using 635 nm laser with a dose of 3.0 J/cm^2 to small area (2cm x 2cm) of vitiligo once to twice a week for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Not described Receives: Procedure: Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent repigmentation
Measured: 24 clinic visits over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionSep 2012
Why it stopped: 3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat H. Hamzavi, M.D., Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259986
- Sponsor's protocol ID
- IRB6452
- Status last verified
- Sep 2012
- First submitted
- 14 Dec 2010
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recalcitrant Forms of Vitiligo With a Low-energy 635 nm Visible Light Laser
- ClinicalTrials.gov ID
- NCT01259986
- Acronym / sponsor ID
- IRB6452
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Laser, Segmental vitiligo, Acral vitiligo
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is the evaluate the efficacy of using a low-energy 635 nm visible light laser in the treatment of various recalcitrant forms of vitiligo.
Detailed description
Vitiligo is a pigmentary disorder characterized by depigmented and hypopigmented macules and patches. There are forms of vitiligo which are more resistant to treatment, including segmental vitiligo and acral vitiligo. Previous studies have shown that a low energy helium-neon (633 nm) laser can cause increased proliferation of melanocytes and repigmentation in segmental-type vitiligo. The goal of this study is to verify these results and show efficacy in other recalcitrant forms of vitiligo including acral vitiligo and post melanocyte-keratinocyte transplantation vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Procedure: Laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 18 years old
- Have active or stable segmental vitiligo on the neck or face, acral vitiligo, or have undergone recent melanocyte-keratinocyte transplantation procedure (MKTP)
- Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection
- Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
- Agree to follow and undergo all study-related procedures
Key exclusion criteria (7 listed)
- Women who are lactating, pregnant, or planning to become pregnant
- Patients with a recent history of melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
- Patients with a known history of photosensitivity disorders
- Photosensitizing medications may be continued throughout of the study at the discretion of the investigator
- Patients with a known history of melanoma or non-melanoma skin cancers
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 |
|---|---|---|
| Laser treatmentLaser treatment of using 635 nm laser with a dose of 3.0 J/cm^2 to small area (2cm x 2cm) of vitiligo once to twice a week for a total of 12 weeks. | Procedure or surgery | Laser treatment |
Primary outcome
Percent repigmentation
Time frame: 24 clinic visits over 12 weeks
Results and safety
The study was stopped early (reason given: 3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
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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.
Iltefat H. Hamzavi, M.D. principal investigator
Henry Ford Health System
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment in people with Vitiligo, run by Henry Ford Health System.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: 3 patients enrolled, no meaningful repigmentation observed. Recruitment halted.). Results are not available in the source record.
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?
Percent repigmentation (time frame: 24 clinic visits over 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 27 Sep 2012.