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NCT03285490 · ClinicalTrials.gov registry record · Phase 3

A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)

A Phase 3 study, sponsored by Almirall, S.A..

Completed
Registry status
Phase 3
Development phase
351
Enrollment target

NCT03285490: Completed Phase 3 study, sponsored by Almirall, S.A..

NCT03285490 is a Phase 3 study that has completed, run by Almirall, S.A.. The registered enrollment target is 351 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03285490, a Phase 3 study, has completed, sponsored by Almirall, S.A..

COMPLETED
Registry status
Phase 3
Development phase
351 participants
Enrollment target

Study Summary

This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.

Primary Outcome

Complete clearance rate was defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.

Interventions

  • DRUG Placebo
  • DRUG KX2-391 Ointment 1%

Trial Details

FieldValue
Enrollment Target 351 participants
Start Date 2017-09-15
Est. Completion 2019-04-24
Phase Phase 3
Almirall, S.A.

19 total trials

What the finished NCT03285490 record still lists

NCT03285490 is an interventional study that assigns participants to a tested intervention. The registered 351 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 (55% lower).

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

NCT03285490 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03285490 about?

NCT03285490 is a clinical study titled "A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)". This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.

What is the current status of trial NCT03285490?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 351 participants. The study started on 2017-09-15. Estimated completion is 2019-04-24.

What interventions are being tested in trial NCT03285490?

The interventions under investigation include: Placebo (DRUG), KX2-391 Ointment 1% (DRUG).

Who is sponsoring clinical trial NCT03285490?

This trial is sponsored by Almirall, S.A., which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03285490's enrollment target sits among peer trials

351 1033rd of 2000 higher than 967 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 NCT03285490, the US trial registry maintained by the National Library of Medicine. NCT03285490 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.