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Principal Investigator has left Sponsoring Instiution
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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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Joyce Teng, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin, Madison | Madison | Wisconsin | 53715 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Cohort Obervational |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Adolescents and young adults treated with systemic isotretinoin for recalcitrant inflammatory or nodular cystic acne.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Cohort Observational |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | U/L | Baseline to 5 months post therapy |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Cohort Observational |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | (full body questionnaire) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dermatology Clinical Trials Administrator | University of Wisconsin - Madison | 608-287-2640 | dbock@dermatology.wisc.edu |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 15 |
| 8 |
| 15 |
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