Clinical trial NCT02120456: Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Official title: Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle


Eligibility criteria: Inclusion Criteria:

* Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
* Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
timeFrame: From Day 1 up to and including Day 8
measure: Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count
timeFrame: From baseline to Week 8
Secondary outcomes:
measure: Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])
timeFrame: From baseline to Week 8
measure: Part 2: Participants With Partial Clearance of AKs (LOCF)
timeFrame: From baseline to Week 8
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Omni Dermatology
state: Arizona
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
city: San Diego
country: United States
facility: Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
state: California
city: Coral Gables
country: United States
facility: Dermatology Associates and Research
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida
state: Florida
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Evansville
country: United States
facility: Hudson Dermatology, LLC
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trials Center
state: Indiana
city: Rockville
country: United States
facility: DermAssociates, PC
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pflugerville
country: United States
facility: Pflugerville Dermatology Clinical Research Center, Inc.
state: Texas
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical
state: British Columbia
city: Vancouver
country: Canada
facility: Skin Care Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic Dermatology Research
state: Manitoba
city: Barrie
country: Canada
facility: UltraNova Skincare
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research Incorporated
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
Study officials:
affiliation: Mount Sinai School of Medicine, Dermatology Faculty
name: Gary Goldenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: