Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-05

Study Completion Date

2016-01-27

Brief Summary

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This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.

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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LFX453 0.1% NMC

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications

Group Type EXPERIMENTAL

Investigational Treatment

Intervention Type DRUG

Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.

LFX453 0.15% LCC

LFX453 0.15% liquid crystal cream (LCC) Twice daily applications

Group Type EXPERIMENTAL

Investigational Treatment

Intervention Type DRUG

Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.

Vehicle to NMC

Vehicle to nanomedicinal cream (NMC) Twice daily applications

Group Type PLACEBO_COMPARATOR

Investigational Treatment

Intervention Type DRUG

Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.

Vehicle to LCC

Vehicle to liquid crystal cream (LCC) Twice daily applications

Group Type PLACEBO_COMPARATOR

Investigational Treatment

Intervention Type DRUG

Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.

Aldara

Aldara cream 3 applications per week

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type DRUG

Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.

Interventions

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Investigational Treatment

Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.

Intervention Type DRUG

Active comparator

Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 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 ears) and/or balding scalp
* Presence of at least one additional visible or palpable non hyperkeratotic AK lesion outside of the selected area amenable to the collection of a skin biopsy, and located at least at 2 cm from the limits of the area to receive treatment
* Male patients had to agree to use adequate contraception for the duration of the study.

Exclusion Criteria

* Known hypersensitivity to any constituents of the study drugs (including local anesthetics if consenting to biopsies) 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 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.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* History of hypertrophic scarring.
* Concurrent disease that suppresses the immune system.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No