In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

NCT00771355 | Terminated

• 1 other identifier: 2008-P-001137/1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo; Melasma; Hyperpigmentation; Hypopigmentation

Outcome Measures

Primary Outcomes (1)

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

  study visit

Study Arms (4)

1

Subjects with vitiligo.

2

Subjects with melasma.

3

Subjects with post-inflammatory hyper-pigmentation.

4

Subjects with post-inflammatory hypo-pigmentation.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Clinical Unit for Research Trials in Skin

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 7769264 BACKGROUND

MeSH Terms

Conditions

Vitiligo; Melanosis; Hyperpigmentation; Hypopigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ernesto Gonzalez, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 13, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 30, 2011

Record last verified: 2011-03

Locations

US (1)