A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp

NCT05231044 | Completed Phase 3

• 1 other identifier: B21-301
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 20

Brief Summary

This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis; Skin disease

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions

  Complete clearance rate is defined as the percentage of participants at Day 57 with no clinically visible AK lesions in the treatment area.

  Day 57

Secondary Outcomes (6)

• Partial Clearance Rate of AK Lesions at Day 57

  Day 57

• Recurrence rate of AK lesions in subjects who achieved complete clearance at Day 57

  3, 6, 9 and 12 months post-Day 57

• Number of participants with local skin reactions (LSR) in the treatment area

  Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57

• Number of participants with pigmentation and scarring in the treatment area

  Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57

• Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs), events of special interest

  From Baseline (Day 1 predose) up to Day 57

Study Arms (2)

KX01 Ointment 1%

EXPERIMENTAL

KX01 Ointment 1% is applied topically once daily for 5 consecutive days on face or scalp

Drug: KX01 ointment 1%

Placebo

PLACEBO COMPARATOR

Vehicle Ointment is applied topically once daily for 5 consecutive days on face or scalp

Drug: Placebo

Interventions

KX01 ointment 1% DRUG

The experimental drug, KX01 Ointment 1% is used in participants with Clinically typical AK on the face or scalp.

KX01 Ointment 1%

Placebo DRUG

Vehicle Ointment is used in participants with Clinically typical AK on the face or scalp.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese Males and females ≥20 years old
• A treatment area on the face or scalp that:
• is a contiguous area measured 25 cm2
• contains more than 1 clinically typical, visible, and discrete AK lesions
• Subjects who, in the judgment of the Investigator or Sub-investigator, are in good general health based on:
• medical history
• physical examination (PE) findings
• vital signs
• clinical chemistry, hematology, and urinalysis results
• Females must be postmenopausal (\>45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, women with childbearing potential must use highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive implant, injection or patch, intrauterine device, or complete abstinence from sexual intercourse.
• Sexually active males who have not had a vasectomy and whose partner is reproductively capable must agree to use barrier contraception from Screening until 90 days after their last dose of study treatment.
• All subjects must agree not to donate sperm or eggs or attempt conception from Screening until 90 days following their last dose of study treatment.
• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to randomization.
• Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp

You may not qualify if:

• Clinically atypical and / or rapidly changing AK lesions on the treatment area, e.g., hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and / or cutaneous horn
• Location of the treatment area is:
• On any location other than the face or scalp
• Within 5 cm of an incompletely healed wound
• Within 5 cm of a suspected basal cell carcinoma (BCC) or SCC
• Been previously treated with KX01 Ointment
• Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
• Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the treatment area or within 2 cm of the treatment area, within 8 weeks prior to the Screening visit
• Use of the following therapies and / or medications within 2 weeks prior to the Screening visit:
• Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area
• Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area
• Topical salves (non-medicated / non-irritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area
• Use of the following therapies and / or medications within 4 weeks prior to the Screening visit:
• Treatment with immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate), or interferons / interferon inducers

Sponsors & Collaborators

• PharmaEssentia: lead
• PharmaEssentia Japan K.K.: collaborator

Study Sites (20)

Toho University Medical Center Sakura Hospital

Chiba, Japan

Location

Kiryu Dermatology Clinic

Fukuoka, Japan

Location

Tomoko Matsuda dermatology Clinic

Fukuoka, Japan

Location

Takamatsu Red Cross Hospital

Kagawa, Japan

Location

Hashiguchi Dermatology

Kagoshima, Japan

Location

Katahira Dermatology and Urology

Kagoshima, Japan

Location

National Hospital Organization Sagamihara National Hospital

Kanagawa, Japan

Location

Nippon Medical School Musashi Kosugi Hospital

Kanagawa, Japan

Location

Kumamoto University Hospital

Kumamoto, Japan

Location

Noguchi Dermatology Clinic

Kumamoto, Japan

Location

Suizenji Dermatology Clinic

Kumamoto, Japan

Location

Futaba Dermatology and Skin Surgery Clinic

Miyazaki, Japan

Location

Toyama Hifuka

Miyazaki, Japan

Location

Okayama Saiseikai Outpatient Center Hospital

Okayama, Japan

Location

Medical Corporation Ayumi Sakurakai Dermatology Ophthalmology Kume Clinic

Osaka, Japan

Location

Mochidahifuka

Osaka, Japan

Location

Juntendo University Hospital

Tokyo, Japan

Location

NTT Medical Center Tokyo

Tokyo, Japan

Location

Toyama Prefectural Central Hospital

Toyama, Japan

Location

University of Yamanashi Hospital

Yamanashi, Japan

Location

MeSH Terms

Conditions

Keratosis, Actinic; Skin Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study tests KX01 Ointment 1% against a placebo.

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: December 21, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

JP (20)