Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

Stopped early

Conditions studied: Acne

In brief

This is a prospective study, that will follow participants over their course of treatment on Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are registered in iPLEDGE. The iPLEDGE program involves a set of steps that the patient, physician and pharmacist must follow for the patient to take Isotretinoin. Patients will be asked if they are willing to participate in this research study to determine musculoskeletal changes in adolescents and young adults on systemic therapy using the highly sensitive magnetic resonance (MR) imaging modality. In addition to the MRI, participants will be asked if they are willing to give an extra sample of blood when their routine blood work is being done for iPLEDGE. This blood sample will be used to determine if there are any effects of isotretinoin on bone turnover markers.

Key facts

Study ID

NCT00964119

Run by

University of Wisconsin, Madison

People needed

15

Starts

2008-07-01

Expected to finish

2013-08-01

Last updated by the study team

2015-02-23

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Registered in I-Pledge and has not started the Isotretinoin medication
• Females and males ages 12-21 years old
• Able to undergo 3 MRI scan

You may not qualify if…

• Participants taking additional vitamin A, D or Calcium supplements
• Previous musculoskeletal injuries (from incidental trauma, sports related injury or motorvehicle accidents, etc)
• Clinical diagnosis of psoriasis, rheumatoid arthritis and/or Reiter's disease
• relocation within the next 6 months
• participation on a research study involving drug medication within the past 30 days

Where it is running

• University of Wisconsin, Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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