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
Phase 3 study of KX01 Ointment 1% in Japanese Actinic Keratosis
Kawase Hiroaki
PharmaEssentia Japan KK
1-3-13 Motoakasaka, Minato-ku, Tokyo
+81-3-6910-5103
hiroaki_kawase@pharmaessentia.com
Kawase Hiroaki
PharmaEssentia Japan KK
1-3-13 Motoakasaka, Minato-ku, Tokyo
+81-3-6910-5103
hiroaki_kawase@pharmaessentia.com
Not Recruiting
Jan. 14, 2022
Dec. 21, 2021
100
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
treatment purpose
1) Japanese Males and females >=20 years old who are diagnosed AK by skin biopsy
2) A treatment area on the face or scalp that:
(a) is a contiguous area measured 25 square centimeters
(b) 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:
(a) medical history
(b) physical examination (PE) findings
(c) vital signs
(d) ECGs, 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 sign the informed consent form 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
9) Able to comprehend and are willing to sign the informed consent form (ICF).
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
- Treatment with systemic medications that suppress the immune system (e.g., cyclosporine, prednisone, methotrexate, infliximab)
8) Use of systemic retinoids (e.g., bexarotene) within 6 months prior to the Screening visit
9) A history of sensitivity and / or allergy to any of the ingredients in the study medication
10) A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., scarring, open wounds) that, in the opinion of the Investigator or Sub-investigator, might interfere with the study conduct or evaluations, or which exposes the subject to an unacceptable risk by study participation
11) Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator or Sub-investigator, would expose the subject to an unacceptable risk by study participation
12) Females who are pregnant or nursing
13) Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing
20age old over
No limit
Both
Actinic keratosis
Apply KX01 ointment 1%
Actinic keratosis
Safety, e.g. AE, evaluation
PharmaEssentia Japan KK
Institutional Review Board of Juntendo University Hospital
