In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

Vitiligo Clinical Trial

Official title:

In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00771355
• Other study ID #: 2008-P-001137/1
• Status: Terminated
• Phase: N/A
• First received: October 9, 2008
• Last updated: March 28, 2011
• Start date: August 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperpigmentation
• Hypopigmentation
• Melasma
• Vitiligo

Locations

Country	Name	City	State
United States	Clinical Unit for Research Trials in Skin	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe characteristic features seen by confocal microscopy of several pigmentary disorders.		study visit	No