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

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Drug: Ingenol mebutate gel, 0.015%; Drug: Vehicle gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01600014

2011-005018-13 (EudraCT Number)

LP0041-22

Details and patient eligibility

About

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.

Enrollment: 463 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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463 participants in 2 patient groups, including a placebo group

Ingenol mebutate gel, 0.015%

Active Comparator group

Description:

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

Treatment:

Drug: Ingenol mebutate gel, 0.015%

Vehicle gel

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle gel