Overview

This trial is active, not recruiting.

Condition acne
Sponsor University of Wisconsin, Madison
Start date July 2008
End date February 2010
Trial size 65 participants
Trial identifier NCT00964119, H-2008-0106

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Eligibility Criteria

Male or female participants from 12 years up to 21 years old.

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

Additional Information

Official title An Interdisciplinary Study of Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population
Principal investigator Joyce Teng, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.