Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

February 11, 2015 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • University of Wisconsin, Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal Toxicities Related to the Use of Isotretinoin
Time Frame: Baseline to 5 months post therapy
Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy
Baseline to 5 months post therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Joyce Teng, MD, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

August 21, 2009

First Submitted That Met QC Criteria

August 21, 2009

First Posted (ESTIMATE)

August 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2008-0106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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