In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

This study has been terminated.
(Lack of study staff.)
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00771355
First received: October 9, 2008
Last updated: March 28, 2011
Last verified: March 2011

October 9, 2008
March 28, 2011
August 2008
July 2010   (final data collection date for primary outcome measure)
To describe characteristic features seen by confocal microscopy of several pigmentary disorders. [ Time Frame: study visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00771355 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy
In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Vitiligo
  • Melasma
  • Hyperpigmentation
  • Hypopigmentation
Not Provided
  • 1
    Subjects with vitiligo.
  • 2
    Subjects with melasma.
  • 3
    Subjects with post-inflammatory hyper-pigmentation.
  • 4
    Subjects with post-inflammatory hypo-pigmentation.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
July 2010
July 2010   (final data collection date for primary outcome measure)

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 informed consent.
  4. Able to complete study and comply with study procedures.

Exclusion Criteria:

  1. Use of topical therapies such as corticosteroids, 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. 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.
  5. Subjects who are known to be pregnant or planning a pregnancy.
Both
20 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00771355
2008-P-001137/1
No
Ernesto Gonzalez, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Ernesto Gonzalez, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP