study in patients with actinic keratosis (an disease of the skin) with the aim to evaluate the efficacy, the safety and the pharmacokinetics (way the body absorbs, distributes, and gets ride of the drug) of LFX453 after multiple applications to the skin

• Register: EUCTR
• Last refreshed on: 30 May 2016
• Main ID: EUCTR2014-003613-28-AT
• Date of registration: 05/11/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: study in patients with actinic keratosis (an disease of the skin) with the aim to evaluate the efficacy, the safety and the pharmacokinetics (way the body absorbs, distributes, and gets ride of the drug) of LFX453 after multiple applications to the skin
• Scientific title: A randomized, vehicle controlled, active comparator, parallel group study to evaluate safety, tolerability and preliminary efficacy of topical LFX453 formulations in patients with actinic keratosis - Safety, tolerability and efficacy study of LFX453 in actinic keratosis patients
• Date of first enrolment: 17/12/2014
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003613-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Denmark, Germany, Iceland, United Kingdom

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Pharma GmbH

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion 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:
• 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Actinic keratosis
MedDRA version: 18.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

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: Cream
Route of administration of the placebo: Topical use (Noncurrent)

Product Code: LFX453
Pharmaceutical Form: Cream
Current Sponsor code: LFX453
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.15-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Topical use (Noncurrent)

Trade Name: Aldara
Product Name: Aldara
Pharmaceutical Form: Cream
INN or Proposed INN: IMIQUIMOD
CAS Number: 99011-02-6
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

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

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

Timepoint(s) of evaluation of this end point: week 20

Secondary Outcome(s)

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

Secondary ID(s)

CLFX453X2201

Source(s) of Monetary Support

Novartis Pharma services AG