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Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne

Phase: N/A

Status: Terminated

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Joyce Teng, MD, PhD, Principal Investigator, Affiliation: University of Wisconsin, Madison

Summary

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.

Clinical Details

Official title: An Interdisciplinary Study of Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Skeletal Toxicities Related to the Use of Isotretinoin

Eligibility

Minimum age: 12 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Registered in I-Pledge and has not started the Isotretinoin medication 2. Females and males ages 12-21 years old 3. Able to undergo 3 MRI scan Exclusion Criteria: 1. Participants taking additional vitamin A, D or Calcium supplements 2. Previous musculoskeletal injuries (from incidental trauma, sports related injury or motorvehicle accidents, etc) 3. Clinical diagnosis of psoriasis, rheumatoid arthritis and/or Reiter's disease 4. relocation within the next 6 months 5. participation on a research study involving drug medication within the past 30 days

Locations and Contacts

University of Wisconsin, Madison, Madison, Wisconsin 53715, United States
Additional Information

Starting date: July 2008
Last updated: February 11, 2015

Page last updated: August 23, 2015

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