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

Actinic Keratosis Clinical Trial

Official title:

Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549339
• Other study ID #: LP0084-1194
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2015
• Est. completion date: August 10, 2017

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: August 10, 2017
• Est. primary completion date: August 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• LEO 43204 gel

• Vehicle gel

Locations

Country	Name	City	State
United States	Laser & Skin Surgery Center of Indiana	Carmel	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Clearance of Actinic Keratosis (AK)	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.	At Week 8
Secondary	Percentage of Participants With Partial Clearance (Multiple Imputation)	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.	At Week 8
Secondary	Percentage of Participants With Partial Clearance (Multiple Imputation)	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.	At Week 4
Secondary	Percent Reduction in AK Count in the Treatment Area Compared to Baseline	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.	At Week 8

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