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

Actinic Keratosis Clinical Trial

Official title:

Efficacy and Safety of Ingenol Mebutate Gel in Field Treatment of Actinic Keratosis on Full Face, Balding Scalp or Approximately 250 cm2 on the Chest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361216
• Other study ID #: LP0105-1032
• Status: Completed
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: March 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 729
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Ingenol Mebutate

Other:
• Vehicle
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	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	Percentage of Participants With Partial Clearance at Week 8	Partial clearance (AKclear75 ) is defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.	8 weeks
Secondary	Percentage of Participants With Partial Clearance at Week 4	Partial clearance (AKclear75) defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.	4 weeks
Secondary	Percent Reduction From Baseline in AK Count	Percent reduction in AK count in the selected treatment area at Week 8	8 weeks