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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02404389
• Date of registration: 23/01/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients
• 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
• Date of first enrolment: March 5, 2015
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02404389
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Denmark, Germany, Iceland, United Kingdom

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Key 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.

Key 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Actinic Keratosis

Intervention(s)

Drug: Investigational Treatment

Drug: Active comparator

Primary Outcome(s)

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 [Time Frame: Baseline, Week 20]

Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks [Time Frame: 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 [Time Frame: Week 20]

Secondary Outcome(s)

Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined [Time Frame: week 8, week 16]

Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined [Time Frame: week 8, week 16]

Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined [Time Frame: Baseline, Week 8]

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 [Time Frame: Week 20]

Secondary ID(s)

CLFX453X2201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02404389