NCT02424305

Brief 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 15 clinically typical, visible, and discrete actinic keratosis (AKs) on the face, 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 LEO43204 gel 0.018% on the full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 24, 2025

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

April 14, 2015

Last Update Submit

February 21, 2025

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC) of LEO 43204.

    Once daily for 3 days

  • Peak Plasma Concentration (Cmax) of LEO 43204.

    Once daily for 3 days

Study Arms (3)

face: LEO 43204 gel 0.018%

EXPERIMENTAL

3 days treatment (once daily) on face: LEO 43204 gel 0.018%

Drug: LEO 43204 gel 0.018%

arm: LEO 43204 gel 0.1%

EXPERIMENTAL

3 days treatment (once daily) on arm: LEO 43204 gel 0.1%

Drug: LEO 43204 gel 0.1%

scalp: LEO 43204 gel 0.037%

EXPERIMENTAL

3 days treatment (once daily) on scalp: LEO 43204 gel 0.037%

Drug: LEO 43204 gel 0.037%

Interventions

LEO 43204 gel 0.018%DRUG
face: LEO 43204 gel 0.018%
LEO 43204 gel 0.1%DRUG
arm: LEO 43204 gel 0.1%
LEO 43204 gel 0.037%DRUG
scalp: LEO 43204 gel 0.037%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with 15 or more clinically typical, visible and discrete AKs on either:
  • Full face (corresponding to a treatment area of at least 250 cm2). If subjects have a beard they must shave no later than the day before the first drug application.
  • A contiguous area of approximately 250 cm2 on the arm between wrist and shoulder.
  • Balding scalp (corresponding to a treatment area of approximately 250 cm2). Subjects with sparse hair on the scalp can be enrolled as long as LSR and AK assessments are not compromised.
  • Subject at least 18 years of age.
  • Female subjects of childbearing potential\* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
  • Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.

You may not qualify if:

  • Location of the treatment area (full face, full balding scalp, chest, trunk or extremities)
  • within 5 cm of an incompletely healed wound.
  • within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
  • Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
  • Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns)and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pflugerville Dermatology Clinical Research

Pflugerville, Texas, 7866, United States

Location

Related Publications (1)

  • Lain E, Skov T, Hall A. Pharmacokinetics and Safety of Ingenol Disoxate Gel Administered Under Maximum-Use Conditions to Patients With Actinic Keratosis. Clin Drug Investig. 2018 Mar;38(3):249-257. doi: 10.1007/s40261-017-0608-y.

    PMID: 29204958DERIVED

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Edward Lain, MD

    Pflugerville Dermatology Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 23, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 24, 2025

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)