ClinicalTrials.gg
TerminatedNCT00771355Updated Mar 30, 2011

In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

An observational study in Vitiligo, Melasma and Hyperpigmentation, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-30.

Sponsored by Massachusetts General Hospital · Observational

Why this study was terminated
Lack of study staff.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
20 Years to 70 Years
Sex
All
01

Study 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. Confocal Microscopy is a recent diagnostic technique that has been used for observation of skin conditions that affect the superficial layers of the skin.

02

Conditions studied

  • Vitiligo
  • Melasma
  • Hyperpigmentation
  • Hypopigmentation
03

In context

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

This study's planned enrollment of 40 is below the median of 114 across 67 observational studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subjects 20-70 years of age.
  2. Clinical diagnosis of vitiligo, melasma, post-inflammatory hypo or depigmentation or post-inflammatory hyperpigmentation.
  3. Willing and able to understand and sign .
  4. Able to complete study and comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Use of topical therapies such as , protopic, hydroquinone and azelaic acid within the past 2 months.
  2. Use of light therapy such as narrow-band-UVB, PUVA or laser within the past 2 months.
  3. 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)
    • Tetracyclines (including minocycline, doxycycline)
    • Amiodarone
    • Azidothymidine
    • Clofazimine
  4. 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.
  5. Subjects who are known to be pregnant or planning a pregnancy.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)

Groups and cohorts

  • 1

    Subjects with vitiligo.

  • 2

    Subjects with melasma.

  • 3

    Subjects with post-inflammatory hyper-pigmentation.

  • 4

    Subjects with post-inflammatory hypo-pigmentation.

06

What researchers measure

Primary outcomes

  1. To describe characteristic features seen by confocal microscopy of several pigmentary disorders.

    Time frame: study visit

07

Study locations

1 site
  • Clinical Unit for Research Trials in Skin
    Boston, Massachusetts 02114, United States
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2008, a primary completion of Jul 2010 and a completion of Jul 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2008
First posted
Oct 13, 2008
Start
Aug 2008
Primary completionEst.
Jul 2010
CompletionEst.
Jul 2010
Last update
Mar 30, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00771355
First posted
Oct 13, 2008
Start date
Aug 2008
Primary completion
Jul 2010 (estimated)
Completion
Jul 2010 (estimated)
Last update
Mar 30, 2011

Study contacts

Ernesto Gonzalez, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion