Brief Title
Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia
Brief Summary
Acanthosis Nigricans is skin disease that associated with hyperinsulinemia. Clinical is
velvety hyperpigmented plaques on neck, axilla, groin. If hyperinsulinemia is improved by
treated with oral metformin and/ or diet control, acanthosis nigricans would be improved as
well. Hyperpigmented plaques will be changed. We assess objective measurement by using
spectroscopic and colorimetric analysis.
Study Type
Observational
Condition
Acanthosis Nigricans
Intervention
Metformin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
February 2009
Completion Date
June 2012
Primary Completion Date
June 2012
Eligibility Criteria
Inclusion Criteria:
1. Subjects must have an elevated fasting insulin level, suggesting they are in an
insulin resistant state.
2. Subjects must carry a diagnosis of acanthosis nigricans, which will be verified by a
Dermatologist before entry into the study. If necessary, a small 4mm punch biopsy may
be taken to document dermatopathology consistent with acanthosis nigricans.
3. Subjects must be willing and able to undergo treatment with Metformin, including
initial referral and follow up.
4. Agree to abide by the investigator's guidelines
5. Be able to understand the requirements of the study, the risks involved and are able
to sign the informed consent form
6. Agree to follow and undergo all study-related procedures
Exclusion Criteria:
1. Subjects with Type 1 Diabetes are excluded because of their naturally
insulin-deficient, rather than hyper-insulinemic, states.
2. Women who are lactating, pregnant, or planning to become pregnant.
3. Any reason the investigator feels the patient should not participate in the study.
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Gender
All
Ages
11 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Iltefat Hamzavi, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01125150
Organization ID
IRB5339
Responsible Party
Principal Investigator
Study Sponsor
Henry Ford Health System
Study Sponsor
Iltefat Hamzavi, M.D., Principal Investigator, Department of Dermatology, Henry Ford Hospital
Verification Date
May 2010