Clinical trial NCT02424305: Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions
Official title: Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Subject at least 18 years of age.
3. Female subjects of childbearing potential\* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
4. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.

Exclusion Criteria:

1. 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.
2. Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
3. 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).

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of LEO 43204.
timeFrame: Once daily for 3 days
measure: Peak Plasma Concentration (Cmax) of LEO 43204.
timeFrame: Once daily for 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pflugerville
country: United States
facility: Pflugerville Dermatology Clinical Research
state: Texas
Study officials:
affiliation: Pflugerville Dermatology Clinical Research
name: Edward Lain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.