Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No