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

NCT02404389 | Completed Phase 2 Results

• 1 other identifier: CLFX453X2201
• Study Type: interventional
• Target: 82
• Locations: 5 countries
• Sites: 10

Brief Summary

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.

Conditions

Actinic Keratosis

Keywords

Actinic keratosis, patients, topical, lesion count, clearance rate

Outcome Measures

Primary Outcomes (3)

• Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks

  Number of participants with at least one AE/SAE in the category up to 20 weeks

  20 weeks

• Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

  Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

  Week 20

• Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

  Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

  Baseline, Week 20

Secondary Outcomes (4)

• Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined

  week 8, week 16

• Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

  Week 20

• Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined

  week 8, week 16

• Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined

  Baseline, Week 8

Study Arms (5)

LFX453 0.1% NMC

EXPERIMENTAL

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications

Drug: Investigational Treatment

LFX453 0.15% LCC

EXPERIMENTAL

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

Drug: Investigational Treatment

Vehicle to NMC

PLACEBO COMPARATOR

Vehicle to nanomedicinal cream (NMC) Twice daily applications

Drug: Investigational Treatment

Vehicle to LCC

PLACEBO COMPARATOR

Vehicle to liquid crystal cream (LCC) Twice daily applications

Drug: Investigational Treatment

Aldara

ACTIVE COMPARATOR

Aldara cream 3 applications per week

Drug: Active comparator

Interventions

Investigational Treatment 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 0.1% NMC; LFX453 0.15% LCC; Vehicle to LCC; Vehicle to NMC

Active comparator 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.

Aldara

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Vienna, 1040, Austria

Location

Novartis Investigative Site

Copenhagen NV, DK-2400, Denmark

Location

Novartis Investigative Site

Berlin, 10098, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Bonn, 53111, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Kopavogur, 201, Iceland

Location

Novartis Investigative Site

London, E1 1BB, United Kingdom

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Therapies, Investigational

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: March 31, 2015
• Study Start: March 5, 2015
• Primary Completion: January 27, 2016
• Study Completion: January 27, 2016
• Last Updated: January 5, 2021
• Results First Posted: March 19, 2018

Record last verified: 2019-03

Locations

GB (1); IC (1); AU (1); DK (1); DE (6)