In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

This study is currently recruiting participants.

Verified by Massachusetts General Hospital, October 2008

First Received: October 9, 2008 No Changes Posted

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00771355

Purpose

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.

Condition
Vitiligo Melasma Hyperpigmentation Hypopigmentation

MedlinePlus related topics: Vitiligo

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To describe characteristic features seen by confocal microscopy of several pigmentary disorders. [ Time Frame: study visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	August 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Subjects with vitiligo.
2 Subjects with melasma.
3 Subjects with post-inflammatory hyper-pigmentation.
4 Subjects with post-inflammatory hypo-pigmentation.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771355

Contacts

Contact: Xinaida Lima, MD

6177261660

Locations

United States, Massachusetts
Clinical Unit for Research Trials in Skin	Recruiting
Boston, Massachusetts, United States, 02114
Contact 617-726-1660
Sub-Investigator: Maria Alora-Palli, MD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Ernesto Gonzalez, MD

Massachusetts General Hospital

More Information

Publications:

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.

Responsible Party:	Massachusetts General Hospital ( Ernesto Gonzalez )
Study ID Numbers:	2008-P-001137/1
Study First Received:	October 9, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00771355 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hypopigmentation
Hyperpigmentation
Skin Diseases
Pigmentation Disorders

Melanosis
Hypomelanotic Disorder
Vitiligo

Additional relevant MeSH terms:

Hypopigmentation
Hyperpigmentation
Skin Diseases

Pigmentation Disorders
Melanosis
Vitiligo

ClinicalTrials.gov processed this record on May 06, 2009