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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: Completed Phase 4 study, sponsored by Sun Pharmaceutical Industries Limited.
NCT02457520 is a Phase 4 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 201 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires. Calculation of the domain scores was accomplished by summing all item responses within each domain. Self-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores r
Interventions
- DRUG Isotretinoin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2015-01-21 |
| Est. Completion | 2018-04 |
| Phase | Phase 4 |
What the finished NCT02457520 record still lists
NCT02457520 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Isotretinoin is the first listed.
NCT02457520 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02457520's enrollment target sits among peer trials
201 406th of 2000 higher than 1,594 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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