VitiligoNCT00771355
In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy
An observational study of Vitiligo and Melasma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a pilot study to evaluate the findings of the Reflectance Confocal Microscopy when performed in cutaneous pigmentary disorders, such as vitiligo, melasma, post-inflammatory hyper-pigmentation and hypo-pigmentation. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo, Melasma, Hyperpigmentation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jul 2010
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects 20-70 years of age with the clinical diagnosis of vitiligo, melasma, post-inflammatory hypo or depigmentation or post-inflammatory hyperpigmentation will be recruited from Dermatology practice at the Massachusetts General Hospital.
Who may be able to join
- Subjects 20-70 years of age.
- Clinical diagnosis of vitiligo, melasma, post-inflammatory hypo or depigmentation or post-inflammatory hyperpigmentation.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
Who cannot join
- Use of topical therapies such as corticosteroids, protopic, hydroquinone and azelaic acid within the past 2 months.
- Use of light therapy such as narrow-band-UVB, PUVA or laser within the past 2 months.
- Intake of medications that can cause pigmentary changes within the past year. Examples are:
- Antimalarials (chloroquine, hydroxychloroquine)
- Chemotherapeutics (bleomycin, busulfan, doxorubicin, daunorubicin, fluorouracil, cyclophosphamide, and carmustine)
- Heavy metals (gold, silver, bismuth, and mercury)
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- Tetracyclines (including minocycline, doxycycline)
- Amiodarone
- Azidothymidine
- Clofazimine
- Clinically significant abnormal findings or conditions (other than the pigmentary disorder), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
- Subjects who are known to be pregnant or planning a pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, 02114
About this study
This is a pilot study to evaluate the findings of the Reflectance Confocal Microscopy when performed in cutaneous pigmentary disorders, such as vitiligo, melasma, post-inflammatory hyper-pigmentation and hypo-pigmentation. Confocal Microscopy is a recent diagnostic technique that has been used for observation of skin conditions that affect the superficial layers of the skin.
- Conditions
- Vitiligo, Melasma, Hyperpigmentation, Hypopigmentation
- Medical subject headings
- Vitiligo, Melanosis, Hyperpigmentation, Hypopigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects with vitiligo. | |
| 2 | Subjects with melasma. | |
| 3 | Subjects with post-inflammatory hyper-pigmentation. | |
| 4 | Subjects with post-inflammatory hypo-pigmentation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe characteristic features seen by confocal microscopy of several pigmentary disorders.
Measured: study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Why it stopped: Lack of study staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ernesto Gonzalez, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771355
- Sponsor's protocol ID
- 2008-P-001137/1
- Status last verified
- Mar 2011
- First submitted
- 9 Oct 2008
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rajadhyaksha M, Grossman M, Esterowitz D, Webb RH, Anderson RR. In vivo confocal scanning laser microscopy of human skin: melanin provides strong contrast. J Invest Dermatol. 1995 Jun;104(6):946-52. doi: 10.1111/1523-1747.ep12606215.
PubMed 7769264
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy
- ClinicalTrials.gov ID
- NCT00771355
- Acronym / sponsor ID
- 2008-P-001137/1
- Conditions
- Vitiligo, Melasma, Hyperpigmentation, Hypopigmentation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of study staff.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 13 Oct 2008 (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.
This is a pilot study to evaluate the findings of the Reflectance Confocal Microscopy when performed in cutaneous pigmentary disorders, such as vitiligo, melasma, post-inflammatory hyper-pigmentation and hypo-pigmentation. Confocal Microscopy is a recent diagnostic technique that has been used for observation of skin conditions that affect the superficial layers of the skin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with vitiligo. |
| 2 | – | –Subjects with melasma. |
| 3 | – | –Subjects with post-inflammatory hyper-pigmentation. |
| 4 | – | –Subjects with post-inflammatory hypo-pigmentation. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 20-70 years of age with the clinical diagnosis of vitiligo, melasma, post-inflammatory hypo or depigmentation or post-inflammatory hyperpigmentation will be recruited from Dermatology practice at the Massachusetts General Hospital.
Key inclusion criteria (4 listed)
- Subjects 20-70 years of age.
- Clinical diagnosis of vitiligo, melasma, post-inflammatory hypo or depigmentation or post-inflammatory hyperpigmentation.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
Key exclusion criteria (12 listed)
- Use of topical therapies such as corticosteroids, protopic, hydroquinone and azelaic acid within the past 2 months.
- Use of light therapy such as narrow-band-UVB, PUVA or laser within the past 2 months.
- Intake of medications that can cause pigmentary changes within the past year. Examples are:
- Clinically significant abnormal findings or conditions (other than the pigmentary disorder), which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
- Subjects who are known to be pregnant or planning a pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe characteristic features seen by confocal microscopy of several pigmentary disorders.
Time frame: study visit
Results and safety
The study was stopped early (reason given: Lack of study staff.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2011.
- Background: PubMed 7769264Rajadhyaksha M, Grossman M, Esterowitz D, Webb RH, Anderson RR. In vivo confocal scanning laser microscopy of human skin: melanin provides strong contrast. J Invest Dermatol. 1995 Jun;104(6):946-52. doi: 10.1111/1523-1747.ep12606215.
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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.
Ernesto Gonzalez, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitiligo and Melasma, run by Massachusetts General Hospital 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 12 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 30 Mar 2011. 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?
The study was stopped early (reason given: Lack of study staff.). 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?
To describe characteristic features seen by confocal microscopy of several pigmentary disorders. (time frame: study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00771355, which also lists 1 linked publication.
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 30 Mar 2011.