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NCT00948428 · ClinicalTrials.gov registry record · Phase 3

Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis

A Phase 3 study, sponsored by Actavis.

Completed
Registry status
Phase 3
Development phase
462
Enrollment target

NCT00948428: Completed Phase 3 study, sponsored by Actavis.

NCT00948428 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 462 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00948428, a Phase 3 study, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 3
Development phase
462 participants
Enrollment target

Study Summary

At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.

Interventions

  • DRUG Vehicle Cream
  • DRUG imiquimod
  • DRUG Aldara™

Trial Details

FieldValue
Enrollment Target 462 participants
Start Date 2008-05
Est. Completion 2009-04
Phase Phase 3
Actavis

79 total trials

What the finished NCT00948428 record still lists

NCT00948428 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 3 interventions - of which Vehicle Cream is the first listed.

NCT00948428 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00948428 about?

NCT00948428 is a clinical study titled "Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis". At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle ...

What is the current status of trial NCT00948428?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2008-05. Estimated completion is 2009-04.

What interventions are being tested in trial NCT00948428?

The interventions under investigation include: Vehicle Cream (DRUG), imiquimod (DRUG), Aldara™ (DRUG).

Who is sponsoring clinical trial NCT00948428?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00948428's enrollment target sits among peer trials

462 821st of 2000 higher than 1,179 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00948428, the US trial registry maintained by the National Library of Medicine. NCT00948428 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.