In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

This study has been terminated.

(Lack of study staff.)

Sponsor:

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00771355

First received: October 9, 2008

Last updated: March 28, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 9, 2008

Last Updated Date

March 28, 2011

Start Date ^ICMJE

August 2008

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00771355 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

Official Title ^ICMJE

In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Vitiligo
Melasma
Hyperpigmentation
Hypopigmentation

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00771355

Other Study ID Numbers ^ICMJE

2008-P-001137/1

Has Data Monitoring Committee

Responsible Party

Ernesto Gonzalez, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ernesto Gonzalez, MD

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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