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
  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

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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ernesto Gonzalez, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Ernesto Gonzalez, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00771355     History of Changes
Other Study ID Numbers: 2008-P-001137/1
Study First Received: October 9, 2008
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperpigmentation
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014