- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02547363
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
December 4, 2018 updated by: LEO Pharma
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
373
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Smithtown, New York, United States, 11787
- Long Island Skin Cancer & Dermatologic Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
- Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area
Exclusion Criteria:
- Location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
- Treatment with ingenol mebutate gel in the treatment area within the last 12 months
- Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
- History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle gel
Treatment once daily for 3 days
|
|
Experimental: LEO 43204
Treatment once daily for 3 days
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
Time Frame: At Week 8
|
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8. Complete clearance was defined as no clinically visible AKs in the treatment area. |
At Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Partial Clearance of AKs
Time Frame: At Week 8
|
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
|
At Week 8
|
Percentage of Participants With Partial Clearance of AKs
Time Frame: At Week 4
|
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
|
At Week 4
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Percent Reduction in AK Count in the Treatment Area Compared to Baseline
Time Frame: At Week 8
|
The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable.
The table presents adjusted mean percent reduction at Week 8 from baseline.
|
At Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel M Siegel, MD, Long Island Skin Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
August 17, 2016
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
September 9, 2015
First Submitted That Met QC Criteria
September 10, 2015
First Posted (Estimate)
September 11, 2015
Study Record Updates
Last Update Posted (Actual)
December 26, 2018
Last Update Submitted That Met QC Criteria
December 4, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP0084-1195
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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