Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis

NCT ID: NCT01820260

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-08-31

Brief Summary

To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1A: Ingenol mebutate gel 0.005%

Open-label, dose escalation, 3 days treatment

Group Type: EXPERIMENTAL

Ingenol mebutate gel

Intervention Type: DRUG

Part 2: Ingenol mebutate gel 0.018% for 3 days treatment

Randomized, 3 days treatment

Group Type: ACTIVE_COMPARATOR

Ingenol mebutate gel

Intervention Type: DRUG

Part 2: Ingenol mebutate gel 0.018% for 2 days treatment

Randomized 2 days treatment

Group Type: ACTIVE_COMPARATOR

Ingenol mebutate gel

Intervention Type: DRUG

Part 2: Ingenol mebutate gel 0.027% for 3 days treatment

Randomized 3 days treatment

Group Type: ACTIVE_COMPARATOR

Ingenol mebutate gel

Intervention Type: DRUG

Part 2: Ingenol mebutate gel 0.027% for 2 days treatment

Randomized 2 days treatment

Group Type: ACTIVE_COMPARATOR

Ingenol mebutate gel

Intervention Type: DRUG

Part 2: Placebo for 3 days treatment

Randomized 3 days treatment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Part 2: Placebo for 2 days treatment

Randomized 2 days treatment

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Part 1A: Ingenol mebutate gel 0.008%

Open-label, dose escalation, 3 days treatment

Group Type: EXPERIMENTAL

Ingenol mebutate gel

Intervention Type: DRUG

Part 1A: Ingenol mebutate gel 0.012%

Open-label, dose escalation, 3 days treatment

Group Type: EXPERIMENTAL

Ingenol mebutate gel

Intervention Type: DRUG

Part 1A: Ingenol mebutate gel 0.027%

Open-label, dose escalation, 3 days treatment

Group Type: EXPERIMENTAL

Ingenol mebutate gel

Intervention Type: DRUG

Part 1A: Ingenol mebutate gel 0.04%

Open-label, dose escalation, 3 days treatment

Group Type: EXPERIMENTAL

Ingenol mebutate gel

Intervention Type: DRUG

Part 1B: Ingenol mebutate gel 0.06%

Open-label, dose escalation, 2 days treatment

Group Type: EXPERIMENTAL

Ingenol mebutate gel

Intervention Type: DRUG

Part 1A: Ingenol mebutate gel 0.018%

Open-label, dose escalation, 3 days treatment

Group Type: EXPERIMENTAL

Ingenol mebutate gel

Intervention Type: DRUG

Part 1B: Ingenol mebutate gel 0.04%

Open-label, dose escalation, 2 days treatment

Group Type: EXPERIMENTAL

Ingenol mebutate gel

Intervention Type: DRUG

Interventions

Ingenol mebutate gel

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects must be competent to understand the nature of the trial and provide informed consent
• Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face, the balding scalp (the balding part of the scalp should be at least 25 cm2) or a contiguous area of approximately 250 cm2 on the chest
• Subject at least 18 years of age
• Female subjects must be of either:

1. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,

2. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy

• Female subjects of childbearing potential1 must be willing to use effective contraception at trial entry and until completion

Exclusion Criteria

• Location of the treatment area (full face, full balding scalp or chest)

• within 5 cm of an incompletely healed wound,
• within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC
• Prior treatment with ingenol mebutate gel within the treatment area
• Lesions in the treatment areas that have:

• atypical clinical appearance (e.g., hypertrophic, 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)
• Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
• Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment
• Any abnormal laboratory tests that are medically significant and would impact the safety of the subjects or the interpretation of the trial results, as determined by the investigator's judgment
• Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications
• Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
• Presence of acute sunburn within the treatment areas
• Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
• Subjects previously assigned to treatment in Part 1 or rand
• Female subjects who are breastfeeding.
• In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C. William Hanke, MD

Role: PRINCIPAL_INVESTIGATOR

Laser & Skin Surgery Center of Indiana

Locations

Laser & Skin Surgery Center of Inidana

Carmel, Indiana, United States

Countries

United States

Other Identifiers

LP0105-1012

Identifier Type: -

Identifier Source: org_study_id