Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

NCT ID: NCT01600014

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 463 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-02-28

Brief Summary

The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ingenol mebutate gel, 0.015%

Topical field treatment once daily for 3 consecutive days on the face or scalp

Group Type: ACTIVE_COMPARATOR

Ingenol mebutate gel, 0.015%

Intervention Type: DRUG

Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%

Vehicle gel

Topical field treatment once daily for 3 consecutive days on the face or scalp

Group Type: PLACEBO_COMPARATOR

Vehicle gel

Intervention Type: DRUG

Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%

Interventions

Ingenol mebutate gel, 0.015%

Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%

Intervention Type: DRUG

Vehicle gel

Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects must provide informed consent
• Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp
• Subject at least 18 years of age
• Female subjects must be of either:

• Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
• Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy
• Female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception

Exclusion Criteria

• Location of the selected treatment area:

• on any location other than the face or scalp
• on the periorbital skin
• 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 on face or scalp (previous treatment on trunk and extremities acceptable)
• Selected treatment area lesions that have atypical clinical appearance
• History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
• Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle
• Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
• Presence of sunburn within the selected treatment area
• Current enrollment or participation in a clinical trial within 30 days of entry into this study
• Subjects previously entered first treatment in the trial
• Female subjects who are breastfeeding
• Subjects who are institutionalised by court order or by the local authority
• In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol

Prohibited Therapies and/or Medications within 2 weeks prior to Day 1

• Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
• Use of keratolytic topical therapeutic products within 2 cm of the selected treatment area
• Use of topical medicated creams, ointments, lotions gels, foams or sprays within 2 cm of the selected treatment area; artificial tanners: within 5 cm of the selected treatment area

Prohibited Therapies and/or Medications: within 4 weeks prior to Day 1

• Treatment with immunomodulators, cytotoxic drugs or interferon /interferon inducers
• Treatment with systemic medications that suppress the immune system
• Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB)

Prohibited Therapies and/or Medications within 8 weeks prior to Day 1

• Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area

Prohibited Therapies and/or Medications within 6 months prior to Day 1

• Use of systemic retinoids or biologic/monoclonal antibody therapies

• 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

Claus Garbe, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

St John of God Dermatology

Subiaco, , Australia

Stratica Medical

Edmonton, Alberta, Canada

Skin Care Centre

Vancouver, British Columbia, Canada

Dermadvances Research

Winnipeg, Manitoba, Canada

Durondel C.P. Inc./Dermatology Clinic

Moncton, New Brunswick, Canada

UltraNova Skincare

Barrie, Ontario, Canada

SKiN Centre for Dermatology

Peterborough, Ontario, Canada

Windsor Clinical Research Inc.

Windsor, Ontario, Canada

Innovaderm Research Inc.

Montreal, Quebec, Canada

Centre de Recherche Dermatologique

Québec, Quebec, Canada

CHU de Nantes

Nantes, Loire-Atlantique 6, France

Universitätsklinikum Tübingen

Tübingen, , Germany

Central Manchester University Hosptial

Manchester, Greater Manchester, United Kingdom

Countries

Australia; Canada; France; Germany; United Kingdom

Related Links

https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

2011-005018-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LP0041-22

Identifier Type: -

Identifier Source: org_study_id