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Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LEO 43204 gel 0.018%

LEO 43204 gel 0.1%

LEO 43204 gel 0.037%

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Pflugerville Dermatology Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

face: LEO 43204 gel 0.018%

arm: LEO 43204 gel 0.1%

scalp: LEO 43204 gel 0.037%

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Peak Plasma Concentration (Cmax) of LEO 43204.

Secondary Outcome Measures

Full Information

NCT ID

NCT02424305

First Posted

April 14, 2015

Last Updated

May 1, 2017

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02424305

Brief Title

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

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

face: LEO 43204 gel 0.018%

Arm Type

Experimental

Arm Description

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

Arm Title

arm: LEO 43204 gel 0.1%

Arm Type

Experimental

Arm Description

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

Arm Title

scalp: LEO 43204 gel 0.037%

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

LEO 43204 gel 0.018%

Intervention Type

Drug

Intervention Name(s)

LEO 43204 gel 0.1%

Intervention Type

Drug

Intervention Name(s)

LEO 43204 gel 0.037%

Primary Outcome Measure Information:

Title

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

Time Frame

Once daily for 3 days

Title

Peak Plasma Concentration (Cmax) of LEO 43204.

Time Frame

Once daily for 3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward Lain, MD

Organizational Affiliation

Pflugerville Dermatology Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pflugerville Dermatology Clinical Research

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

7866

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29204958

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.

Results Reference

derived

Learn more about this trial

Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions

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