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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01600014
First received: May 14, 2012
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Drug: Ingenol mebutate gel, 0.015%
Drug: Vehicle gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Complete clearance of AKs [ Time Frame: 8 weeks after randomisation ] [ Designated as safety issue: No ]
    The complete clearance rates 8 weeks after randomisation will be compared between ingenol mebutate gel, 0.015% and vehicle gel.


Secondary Outcome Measures:
  • Complete clearance of AKs [ Time Frame: at month 12 ] [ Designated as safety issue: No ]
    The complete clearance rate in the selected treatment area through to Month 12

  • Change in AK counts [ Time Frame: 8 weeks after randomisation ] [ Designated as safety issue: No ]
    Change in AK counts in the selected treatment area from randomisation to 8 weeks after randomisation


Enrollment: 463
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ingenol mebutate gel, 0.015%
Topical field treatment once daily for 3 consecutive days on the face or scalp
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%
Placebo Comparator: Vehicle gel
Topical field treatment once daily for 3 consecutive days on the face or scalp
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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600014

Locations
Australia
St John of God Dermatology
Subiaco, Australia, 6008
Canada, Alberta
Stratica Medical
Edmonton, Alberta, Canada, T5K 1X3
Canada, British Columbia
Skin Care Centre
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Manitoba
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, New Brunswick
Durondel C.P. Inc./Dermatology Clinic
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
UltraNova Skincare
Barrie, Ontario, Canada, L4M 6L2
SKiN Centre for Dermatology
Peterborough, Ontario, Canada, K9J 1Z2
Windsor Clinical Research Inc.
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Canada
Centre de Recherche Dermatologique
Quebec, Canada, G1V 4X7
France
CHU de Nantes
Nantes, Loire-Atlantique 6, France, 44000
Germany
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
United Kingdom
Central Manchester University Hosptial
Manchester, Greater Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Claus Garbe, MD University Hospital Tuebingen
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01600014     History of Changes
Other Study ID Numbers: LP0041-22, 2011-005018-13
Study First Received: May 14, 2012
Last Updated: March 13, 2014
Health Authority: Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2014