Actinic keratosis MedDRA version: 18.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Code: LFX453
Pharmaceutical Form: Cream
Current Sponsor code: LFX453
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Crea
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent must be obtained before any assessment is performed. • Male patients, and female patients of non-childbearing potential, age = 18 to = 75 years (at the time of the screening visit), and in general good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. • Patients with at least five (5) clinically typical, visible or palpable non-hyperkeratotic AK lesions within a contiguous area of 25 cm2, or within 2 areas for a maximum total of 25cm2, on the face (at least 2 cm from the periocular areas, lips, nares and excluding ears) and/or balding scalp. • Presence of at least one additional visible or palpable non hyperkeratotic AK lesion outside of the selected treatment area amenable to the collection of a skin biopsy, and located at least 2 cm from the limits of the area to receive treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: • Known hypersensitivity to any constituents of the study drugs (including local anesthetics) or known allergies to imiquimod or to drugs of similar chemical classes or history of serious allergic reaction. • Presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on the face or balding scalp, even outside of the treatment area. • Invasive tumors within the treatment area, e.g., merkel cell carcinoma, melanoma, squamous cell carcinoma (SCC), basal cell carcinoma, the latter being accepted if completely surgically removed. Note: A biopsy of any lesion within the treatment or surrounding area suggestive of malignancy should be performed at the pre-study screening visit. If invasive SCC or other malignant conditions are confirmed within the treatment area, the patient will not be included in the study. • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or Bowen’s disease or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases • Concurrent disease that suppresses the immune system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess tolerability and safety of topical LFX453 formulations in patients with actinic keratosis (AK) • To assess efficacy of LFX453 compared to vehicle in patients with actinic keratosis ;Secondary Objective: • To determine the pharmacokinetics of topical LFX453 formulations • To assess efficacy of LFX453 in treating AK compared to vehicle at week 8 and week 16 ;Primary end point(s): - All safety endpoints (including physical exam, vital signs, ECG, safety laboratory) - Number and type of (serious) adverse events - Local tolerability assessment scores compared to baseline - Proportion of patients achieving total clearance of AK 8 weeks after end of treatment - Reduction from baseline of AK lesion count in treated area 8 weeks after end of treatment - Proportion of patients achieving partial clearance of at least 75% of lesions after 8 weeks follow-up;Timepoint(s) of evaluation of this end point: week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Concentrations of LFX453 measured in skin and plasma samples - Reduction from baseline in AK lesion count in treated area at 4 weeks after end of first treatment cycle (week 8) - Proportion of patients achieving total clearance of AK at 4 weeks after end of first treatment cycle (week 8) and at 4 weeks after end of second treatment cycle (week 16) - Proportion of patients achieving partial clearance of at least 75% of lesions at week 8 and week 16;Timepoint(s) of evaluation of this end point: week 4 | — |
Countries
Austria, Denmark, Germany, Iceland, United Kingdom
Contacts
Public ContactDrug Regulatory Affairs
Novartis Pharma GmbH
Outcome results
None listed