Acne
Conditions
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.
Interventions
None listed
Sponsors
University of Wisconsin, Madison
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal Toxicities Related to the Use of Isotretinoin | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Cohort Observational | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Single Cohort Observational |
|---|---|
| Age, Categorical <=18 years | 14 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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
Time frame: Baseline to 5 months post therapy
Population: Pilot observational study; Principal Investigator left sponsoring institution, data analysis not completed. Data analysis based on interim data (12 subjects). No manuscript published. No final analysis expected. Study has been closed with the local IRB and files archived.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Cohort Observational | Skeletal Toxicities Related to the Use of Isotretinoin | post 5 month isotretinoin therapy | 51.80 U/L | Standard Deviation 24.26 |
| Single Cohort Observational | Skeletal Toxicities Related to the Use of Isotretinoin | Baseline BSAP | 62.73 U/L | Standard Deviation 35.86 |
Comparison: PI and lead author left the institution before publishing data. Study has been closed and data files archived.p-value: <0.05t-test, 2 sided