NCT02100813

Brief Summary

To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2014

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

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

March 6, 2025

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

March 27, 2014

Results QC Date

November 14, 2018

Last Update Submit

February 21, 2025

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (2)

  • Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)

    The number participants experiencing a DLT was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants experiencing a DLT. A DLT was defined as: * Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale * Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT. The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.

    From Day 1 up to and including Day 8

  • Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count

    Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) in the selected treatment area.

    From baseline to Week 8

Secondary Outcomes (2)

  • Part 2: Participants With Complete Clearance of AKs

    From baseline to Week 8

  • Part 2: Participants With Partial Clearance of AKs

    From baseline to Week 8

Study Arms (4)

Part 1: LEO 43204

OTHER

Open-label, dose escalation, 2 days treatment

Drug: LEO 43204

Part 2: LEO 43204 x dose

ACTIVE COMPARATOR

X dose for 2 days treatment

Drug: LEO 43204

Part 2: LEO 43204 Y dose

ACTIVE COMPARATOR

Y dose for 2 days treatment

Drug: LEO 43204

Part 2: Placebo

PLACEBO COMPARATOR

Placebo for 2 days treatment

Drug: Placebo

Interventions

LEO 43204DRUG
Part 1: LEO 43204Part 2: LEO 43204 Y dosePart 2: LEO 43204 x dose
PlaceboDRUG
Part 2: Placebo

Eligibility Criteria

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

You may qualify if:

  • Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp.
  • Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp

You may not qualify if:

  • Location of the treatment area
  • within 5 cm of an incompletely healed wound
  • within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
  • Prior treatment with ingenol mebutate gel on the treatment area
  • Lesions in the treatment areas that have
  • atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or 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)

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

LEO 43204

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Clinical Trial Disclosure Specialist
Organization
LEO Pharma A/S
disclosure@leo-pharma.com
+45 44945888

Study Officials

  • Jonathan Weiss, MD

    Gwinnett Clinical Research Center, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 6, 2025

Results First Posted

February 18, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)