Text Size

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
  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:

MedlinePlus related topics: Vitiligo
U.S. FDA Resources

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
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:
Melanosis
Vitiligo
Hyperpigmentation
 Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013