Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00964119
Recruitment Status :
(Principal Investigator has left Sponsoring Instiution)
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.
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, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
12 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All subjects will be recruited from the UW-Madison, Department of Dermatology located at 1 South Park Street, Madison, Wisconsin. Study flyers and brochures will be posted in the waiting areas and clinic rooms at the UW Dermatology clinics. UW Dermatologist will identify patients that meet study criteria and ask if they are interested in research participation, then they will be referred to study personnel for more information.
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
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