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

NCT02549339 | Completed Phase 3 Results

• 1 other identifier: LP0084-1194
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 1

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

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants With Partial Clearance (Multiple Imputation)

  At Week 8

• Percentage of Participants With Partial Clearance (Multiple Imputation)

  At Week 4

• Percent Reduction in AK Count in the Treatment Area Compared to Baseline

  At Week 8

Study Arms (2)

LEO 43204 gel

EXPERIMENTAL

Treatment once daily for 3 days

Drug: LEO 43204 gel

Vehicle gel

PLACEBO COMPARATOR

Treatment once daily for 3 days

Drug: Vehicle gel

Interventions

LEO 43204 gel DRUG

LEO 43204 gel

Vehicle gel DRUG

Vehicle gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure Specialist
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

Study Officials

• C. William Hanke, MD

  Laser & Skin Surgery Center of Indiana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 15, 2015
• Study Start: November 13, 2015
• Primary Completion: August 5, 2016
• Study Completion: August 10, 2017
• Last Updated: March 10, 2025
• Results First Posted: November 14, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)