Clinical trial NCT00771355: In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy
Official title: In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vitiligo
Melasma
Hyperpigmentation
Hypopigmentation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To describe characteristic features seen by confocal microscopy of several pigmentary disorders.
timeFrame: study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Clinical Unit for Research Trials in Skin
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ernesto Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.