In Vivo Imaging of Pigmentary Disorders by Reflectance Confocal Microscopy

Mass General Brigham

Status: Terminated

Conditions: Vitiligo; Hypopigmentation; Hyperpigmentation; Melasma

Study type: Observational

Funder types: Other

Identifiers

NCT00771355

2008-P-001137/1

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

40 participants in 4 patient groups

1

Description:

Subjects with vitiligo.

2

Description:

Subjects with melasma.

3

Description:

Subjects with post-inflammatory hyper-pigmentation.

4

Description:

Subjects with post-inflammatory hypo-pigmentation.