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NCT02457520 · ClinicalTrials.gov registry record · Phase 4
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
A Phase 4 study, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 4
- Development phase
- 201
- Enrollment target
NCT02457520 is a Phase 4 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 201 participants.
The verdict
NCT02457520, a Phase 4 study, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 201 participants
- Enrollment target
Study Summary
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne. ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or abstinence are included.
Interventions
- DRUG Isotretinoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2015-01-21 |
| Est. Completion | 2018-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02457520
The ClinicalTrials.gov registry entry for NCT02457520 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries Limited, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Isotretinoin is the first listed.
NCT02457520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02457520 about?
NCT02457520 is a clinical study titled "ABSORICA in Patients With Severe Recalcitrant Nodular Acne". This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne. ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for ...
What is the current status of trial NCT02457520?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 201 participants. The study started on 2015-01-21. Estimated completion is 2018-04.
What interventions are being tested in trial NCT02457520?
The interventions under investigation include: Isotretinoin (DRUG).
Who is sponsoring clinical trial NCT02457520?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
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