A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Drug: Ingenol mebutate gel 0.015 %; Drug: Ingenol mebutate gel 0.05 %

Study type: Interventional

Funder types: Industry

Identifiers

NCT01787383

LP0041-64

2012-002863-88 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel

Enrollment: 200 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 face or scalp

• Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities

• Subjects at least 18 years of age

• Female subjects must be of either:

  1. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
  2. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy.

• Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.

Exclusion criteria

• Location of the selected treatment areas:

  • 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/scalp and on trunk/extremities

• Lesions in the selected treatment areas that have:

  • atypical clinical appearance (and/or,
  • recalcitrant disease

• History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication

• Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas

• Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment.

• Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application.

• Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel

• Presence of sunburn within the selected treatment areas

• Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial

• Subjects previously randomised in the trial

• Female subjects who are breastfeeding

• 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 Visit 1:

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

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

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

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

• Use of systemic retinoids or biologic/monoclonal antibody therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Ingenol mebutate gel 0.05 %

Active Comparator group

Treatment:

Drug: Ingenol mebutate gel 0.015 %

Drug: Ingenol mebutate gel 0.05 %

Ingenol mebutate gel 0.015 %

Active Comparator group

Treatment:

Drug: Ingenol mebutate gel 0.015 %

Drug: Ingenol mebutate gel 0.05 %