In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

Terminated

• Conditions: Vitiligo; Melasma; Hyperpigmentation; Hypopigmentation

• Registration Number: NCT00771355
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-13
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-28
• Last Update Posted: 2011-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe characteristic features seen by confocal microscopy of several pigmentary disorders.	study visit

Trial Locations

Locations (1)

Clinical Unit for Research Trials in Skin; 🇺🇸 Boston, Massachusetts, United States