In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

NCT ID: NCT00771355

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Vitiligo Melasma Hyperpigmentation Hypopigmentation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects with vitiligo.

No interventions assigned to this group

2

Subjects with melasma.

No interventions assigned to this group

3

Subjects with post-inflammatory hyper-pigmentation.

No interventions assigned to this group

4

Subjects with post-inflammatory hypo-pigmentation.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Massachusetts General Hospital

Principal Investigators

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Ernesto Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Clinical Unit for Research Trials in Skin

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7769264 (View on PubMed)

Other Identifiers

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2008-P-001137/1

Identifier Type: -

Identifier Source: org_study_id