Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

Actinic Keratosis Clinical Trial

Official title:

Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100813
• Other study ID #: LP0084-1014
• Secondary ID: 2014-000037-23
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: November 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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)

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• LEO 43204

• Placebo

Locations

Country	Name	City	State
United States	Gwinnett Clinical Research Center, Inc.	Snellville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Part 2: Participants With Complete Clearance of AKs	Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in AK count.	From baseline to Week 8
Secondary	Part 2: Participants With Partial Clearance of AKs	Partial clearance of AKs at Week 8 was defined as at least 75% reduction from baseline in AK count.	From baseline to Week 8

External Links

•   Clinical Trials at LEO Pharma