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
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
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
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:
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:
Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities
Lesions in the selected treatment areas that have:
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:
Prohibited Therapies and/or Medications: within 4 weeks prior to Visit 1:
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