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Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up

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ClinicalTrials.gov Identifier: NCT02549339
Recruitment Status : Completed
First Posted : September 15, 2015
Results First Posted : November 14, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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Brief Summary:
The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: LEO 43204 gel Drug: Vehicle gel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 383 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
Actual Study Start Date : November 13, 2015
Actual Primary Completion Date : August 5, 2016
Actual Study Completion Date : August 10, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: LEO 43204 gel
Treatment once daily for 3 days
 Drug: LEO 43204 gel
Placebo Comparator: Vehicle gel
Treatment once daily for 3 days
 Drug: Vehicle gel


Outcome Measures
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Primary Outcome Measures :
  1. 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, Week 4, and Week 8.

    Complete clearance was defined as no clinically visible AKs in the treatment area.

    The table shows the percentage of mean number of subjects across imputations with complete clearance.



Secondary Outcome Measures :
  1. Percentage of Participants With Partial Clearance (Multiple Imputation) [ Time Frame: At Week 8 ]

    The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 4, and Week 8.

    Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

    The table shows the percentage of mean number of participants across imputations with partial clearance.


  2. Percentage of Participants With Partial Clearance (Multiple Imputation) [ Time Frame: At Week 4 ]

    The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 4, and Week 8.

    Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.

    The table shows the percentage of mean number of participants across imputations with partial clearance.


  3. 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 (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest
  • 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 face or chest) 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549339


Locations
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United States, Indiana
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States, 46032
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: C. William Hanke, MD Laser & Skin Surgery Center of Indiana
More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02549339    
Other Study ID Numbers: LP0084-1194
First Posted: September 15, 2015    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: December 5, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms