Clinical trial NCT05231044: A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp
Official title: A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, Safety and PK Study of KX01 Ointment 1% in Japanese Adult Subjects With Actinic Keratosis on the Face or Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Skin disease
Lead sponsor: PharmaEssentia
Sponsor class: INDUSTRY
Collaborators: name: PharmaEssentia Japan K.K.
First posted: 2022-02-09
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study tests KX01 Ointment 1% against a placebo.
Primary purpose: TREATMENT

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.

Detailed description: This study is a double-blinded, multicenter, activity, and safety study of KX01 Ointment administered topically to the face or scalp of participants with actinic keratosis. The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received 5 consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations is performed.

Eligibility criteria: Inclusion Criteria:

1. Japanese Males and females ≥20 years old
2. A treatment area on the face or scalp that:

   1. is a contiguous area measured 25 cm2
   2. contains more than 1 clinically typical, visible, and discrete AK lesions
3. Subjects who, in the judgment of the Investigator or Sub-investigator, are in good general health based on:

   1. medical history
   2. physical examination (PE) findings
   3. vital signs
   4. clinical chemistry, hematology, and urinalysis results
4. 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.
5. 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.
6. 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.
7. 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.
8. Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp

Exclusion Criteria:

1. 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
2. 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
3. Been previously treated with KX01 Ointment
4. Anticipated need for in-patient hospitalization or in-patient surgery from Day 1 to Day 57
5. 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
6. 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
7. 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

Primary outcomes:
measure: Percentage of participants with complete (100%) clearance of Actinic Keratosis (AK) lesions
timeFrame: Day 57
Secondary outcomes:
measure: Partial Clearance Rate of AK Lesions at Day 57
timeFrame: Day 57
measure: Recurrence rate of AK lesions in subjects who achieved complete clearance at Day 57
timeFrame: 3, 6, 9 and 12 months post-Day 57
measure: Number of participants with local skin reactions (LSR) in the treatment area
timeFrame: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57
measure: Number of participants with pigmentation and scarring in the treatment area
timeFrame: Baseline (Day 1 predose), Days 5, 8, 15, 29 and 57
measure: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs), events of special interest
timeFrame: From Baseline (Day 1 predose) up to Day 57
measure: Number of participants with AEs within the treatment area after Day 57 up to 12 months post-Day 57
timeFrame: After Day 57 up to 12 months post-Day 57
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Toho University Medical Center Sakura Hospital
city: Fukuoka
country: Japan
facility: Kiryu Dermatology Clinic
city: Fukuoka
country: Japan
facility: Tomoko Matsuda dermatology Clinic
city: Kagawa
country: Japan
facility: Takamatsu Red Cross Hospital
city: Kagoshima
country: Japan
facility: Hashiguchi Dermatology
city: Kagoshima
country: Japan
facility: Katahira Dermatology and Urology
city: Kanagawa
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
city: Kanagawa
country: Japan
facility: Nippon Medical School Musashi Kosugi Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kumamoto
country: Japan
facility: Noguchi Dermatology Clinic
city: Kumamoto
country: Japan
facility: Suizenji Dermatology Clinic
city: Miyazaki
country: Japan
facility: Futaba Dermatology and Skin Surgery Clinic
city: Miyazaki
country: Japan
facility: Toyama Hifuka
city: Okayama
country: Japan
facility: Okayama Saiseikai Outpatient Center Hospital
city: Osaka
country: Japan
facility: Medical Corporation Ayumi Sakurakai Dermatology Ophthalmology Kume Clinic
city: Osaka
country: Japan
facility: Mochidahifuka
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: NTT Medical Center Tokyo
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Yamanashi
country: Japan
facility: University of Yamanashi Hospital
Study officials:
References: