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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 : Terminated (Principal Investigator has left Sponsoring Instiution)
First Posted : August 24, 2009
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Acne

Study Design

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Interdisciplinary Study of Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population
Study Start Date : July 2008
Primary Completion Date : February 2010
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964119


Locations
United States, Wisconsin
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Joyce Teng, MD, PhD University of Wisconsin, Madison
More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00964119     History of Changes
Other Study ID Numbers: H-2008-0106
First Posted: August 24, 2009    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Isotretinoin
Benzoyl Peroxide
Dermatologic Agents