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OpenTrials
Completed

NCT Number: NCT02424305

Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal 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 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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pflugerville Dermatology Clinical Research

Pflugerville, Texas, 7866, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

LEO 43204 gel 0.018%

Drug

LEO 43204 gel 0.1%

Drug

LEO 43204 gel 0.037%

Drug

Primary outcomes

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

    Time frame: Once daily for 3 days

  2. Peak Plasma Concentration (Cmax) of LEO 43204.

    Time frame: Once daily for 3 days

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2015
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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