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NCT02124239 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions

A Phase 1 study, sponsored by LEO Pharma.

Completed
Registry status
Phase 1
Development phase
79
Enrollment target

NCT02124239: Completed Phase 1 study, sponsored by LEO Pharma.

NCT02124239 is a Phase 1 study that has completed, run by LEO Pharma. The registered enrollment target is 79 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02124239, a Phase 1 study, has completed, sponsored by LEO Pharma.

COMPLETED
Registry status
Phase 1
Development phase
79 participants
Enrollment target

Study Summary

This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 10 clinically typical, visible, and discrete AKs on the face, balding scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin. There will be 3 treatment groups: (1) once daily application of ingenol mebutate gel 0.027% on the full face for three consecutive days, (2) the same regimen on the balding scalp, and (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of approximately 250 cm2 for four consecutive days.

Interventions

  • DRUG Ingenol mebutate

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2014-04
Est. Completion 2014-11
Phase Phase 1
LEO Pharma

65 total trials

What the finished NCT02124239 record still lists

NCT02124239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher).

The record links to 0 conditions, and to 1 intervention - of which Ingenol mebutate is the first listed.

NCT02124239 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02124239 about?

NCT02124239 is a clinical study titled "Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions". This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 10 clinically typical, visible, and discrete AKs on the face,...

What is the current status of trial NCT02124239?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2014-04. Estimated completion is 2014-11.

What interventions are being tested in trial NCT02124239?

The interventions under investigation include: Ingenol mebutate (DRUG).

Who is sponsoring clinical trial NCT02124239?

This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02124239's enrollment target sits among peer trials

79 696th of 2000 higher than 1,304 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02124239, the US trial registry maintained by the National Library of Medicine. NCT02124239 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.