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

NCT01600014 | Completed Phase 3 Results

• 2 other identifiers: LP0041-222011-005018-13
• Study Type: interventional
• Target: 463
• Locations: 5 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation

  The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)

  8 weeks after randomisation

Secondary Outcomes (2)

• Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12

  From last treatment cycle through to Month 12

• The Change in AK Count From Randomisation to 8 Weeks After Randomisation

  8 weeks after randomisation

Study Arms (2)

Ingenol mebutate gel, 0.015%

ACTIVE COMPARATOR

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

Drug: Ingenol mebutate gel, 0.015%

Vehicle gel

PLACEBO COMPARATOR

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

Drug: Vehicle gel

Interventions

Ingenol mebutate gel, 0.015% 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%

Ingenol mebutate gel, 0.015%

Vehicle gel 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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (13)

St John of God Dermatology

Subiaco, 6008, Australia

Location

Stratica Medical

Edmonton, Alberta, T5K 1X3, Canada

Location

Skin Care Centre

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Dermadvances Research

Winnipeg, Manitoba, R3C 1R4, Canada

Location

Durondel C.P. Inc./Dermatology Clinic

Moncton, New Brunswick, E1C 8X3, Canada

Location

UltraNova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 1Z2, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 5L7, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Centre de Recherche Dermatologique

Québec, Quebec, G1V 4X7, Canada

Location

CHU de Nantes

Nantes, Loire-Atlantique 6, 44000, France

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Central Manchester University Hosptial

Manchester, Greater Manchester, M13 9WL, United Kingdom

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 Manager
• Organization: LEO Pharma A/S

ctr.disclosure@leo-pharma.com

+45 44945888

Study Officials

• Claus Garbe, MD

  University Hospital Tuebingen

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 10, 2025
• Results First Posted: May 9, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9); FR (1); AU (1); DE (1); GB (1)