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

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600014
• Other study ID #: LP0041-22
• Secondary ID: 2011-005018-13
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2012
• Last updated: May 6, 2015
• Start date: May 2012
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationGermany: Federal Institute for Drugs and Medical DevicesFrance: Agence Nationale de Sécurité du Médicament et des produits de santéUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• 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%
• 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%

Locations

Country	Name	City	State
Australia	St John of God Dermatology	Subiaco
Canada	UltraNova Skincare	Barrie	Ontario
Canada	Stratica Medical	Edmonton	Alberta
Canada	Durondel C.P. Inc./Dermatology Clinic	Moncton	New Brunswick
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique	Quebec
Canada	Skin Care Centre	Vancouver	British Columbia
Canada	Windsor Clinical Research Inc.	Windsor	Ontario
Canada	Dermadvances Research	Winnipeg	Manitoba
France	CHU de Nantes	Nantes	Loire-Atlantique 6
Germany	Universitätsklinikum Tübingen	Tübingen
United Kingdom	Central Manchester University Hosptial	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Australia,  Canada,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clearance of AKs	The complete clearance rates 8 weeks after randomisation will be compared between ingenol mebutate gel, 0.015% and vehicle gel.	8 weeks after randomisation	No
Secondary	Complete clearance of AKs	The complete clearance rate in the selected treatment area through to Month 12	at month 12	No
Secondary	Change in AK counts	Change in AK counts in the selected treatment area from randomisation to 8 weeks after randomisation	8 weeks after randomisation	No