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NCT03522441 · ClinicalTrials.gov registry record · Phase 3

Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

A Phase 3 study, sponsored by Akorn.

Completed
Registry status
Phase 3
Development phase
1,125
Enrollment target

NCT03522441 is a Phase 3 study that has completed, run by Akorn. The registered enrollment target is 1,125 participants.

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The verdict

NCT03522441, a Phase 3 study, has completed, sponsored by Akorn.

COMPLETED
Registry status
Phase 3
Development phase
1,125 participants
Enrollment target

Study Summary

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.

Interventions

  • DRUG Placebo
  • DRUG Clindamycin 1% Gel

Trial Details

FieldValue
Enrollment Target 1,125 participants
Start Date 2018-04-27
Est. Completion 2019-04-22
Phase Phase 3

Sponsor

Akorn

3 total trials

What the Registry Record Tells You About NCT03522441

The ClinicalTrials.gov registry entry for NCT03522441 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akorn, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03522441 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03522441 about?

NCT03522441 is a clinical study titled "Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris". This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.

What is the current status of trial NCT03522441?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,125 participants. The study started on 2018-04-27. Estimated completion is 2019-04-22.

What interventions are being tested in trial NCT03522441?

The interventions under investigation include: Placebo (DRUG), Clindamycin 1% Gel (DRUG).

Who is sponsoring clinical trial NCT03522441?

This trial is sponsored by Akorn, which has 3 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.