Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00964119
• Other study ID #: H-2008-0106
• Status: Terminated
• Phase: N/A
• First received: August 21, 2009
• Last updated: February 11, 2015
• Start date: July 2008
• Est. completion date: August 2013

Study information

• Verified date: February 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 2013
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 21 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acne

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal Toxicities Related to the Use of Isotretinoin	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	Yes