Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LEO Pharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects must be competent to understand the nature of the trial and 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 use effective contraception.
You may not be if
Location of the selected treatment area:
* on any location other than the face or scalp
* within 5 cm of an incompletely healed wound
* within 10 cm of a suspected basal cell carcinoma (BCC) or SCC
Prior treatment with PEP005 Gel on face or scalp.
Selected treatment area lesions that have:
* atypical clinical appearance and/or
* recalcitrant disease
History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication
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.
Any abnormal vital signs measurements that are medically significant or would impact the safety of the subject or the interpretation of the trial results.
Anticipated need for hospitalization 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 PEP005 Gel
Recent excessive exposure to ultraviolet light
Current enrolment or participation in a clinical trial within 30 days of entry into this study
Subjects previously randomised in the trial
Female subjects who are breastfeeding
Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1
Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
Use of acid-containing therapeutic products within 2 cm of the selected treatment area
Use of topical medicated creams, ointments, lotions, gels, foams or sprays
Prohibited Therapies and/or Medications: within 4 weeks prior to visit 1:
Treatment with immunomodulators, cytotoxic drugs or inter-feron /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-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 visit 1
Use of systemic retinoids or biologic / mono-clonal antibody therapies
Clareo Health | A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
