Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

NCT02361216 | Completed Phase 3 Results

• 1 other identifier: LP0105-1032
• Study Type: interventional
• Target: 729
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)

  Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs

  8 weeks

Secondary Outcomes (3)

• Percentage of Participants With Partial Clearance at Week 8

  8 weeks

• Percentage of Participants With Partial Clearance at Week 4

  4 weeks

• Percent Reduction From Baseline in AK Count

  8 weeks

Study Arms (2)

Ingenol mebutate gel

EXPERIMENTAL

Treatment once daily for 3 days

Drug: Ingenol Mebutate

Vehicle

PLACEBO COMPARATOR

Treatment once daily for 3 days

Other: Vehicle

Interventions

Ingenol Mebutate DRUG

Ingenol mebutate gel

Vehicle OTHER

Vehicle gel

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
• The full face
• The full balding scalp
• A contiguous area of approximately 250 cm2 on the chest

You may not qualify if:

• Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
• Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
• Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
• Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• 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
• 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: February 2, 2015
• First Posted: February 11, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 10, 2025
• Results First Posted: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)