In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00771355

Enrollment

Registered

2008-10-13

Start date

2008-08-31

Completion date

2010-07-31

Last updated

2011-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperpigmentation, Hypopigmentation, Melasma, Vitiligo

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results