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Brief Title: 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 ID: NCT05231044
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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Toho University Medical Center Sakura Hospital, Chiba, , Japan
Kiryu Dermatology Clinic, Fukuoka, , Japan
Tomoko Matsuda dermatology Clinic, Fukuoka, , Japan
Takamatsu Red Cross Hospital, Kagawa, , Japan
Hashiguchi Dermatology, Kagoshima, , Japan
Katahira Dermatology and Urology, Kagoshima, , Japan
National Hospital Organization Sagamihara National Hospital, Kanagawa, , Japan
Nippon Medical School Musashi Kosugi Hospital, Kanagawa, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Noguchi Dermatology Clinic, Kumamoto, , Japan
Suizenji Dermatology Clinic, Kumamoto, , Japan
Futaba Dermatology and Skin Surgery Clinic, Miyazaki, , Japan
Toyama Hifuka, Miyazaki, , Japan
Okayama Saiseikai Outpatient Center Hospital, Okayama, , Japan
Medical Corporation Ayumi Sakurakai Dermatology Ophthalmology Kume Clinic, Osaka, , Japan
Mochidahifuka, Osaka, , Japan
Juntendo University Hospital, Tokyo, , Japan
NTT Medical Center Tokyo, Tokyo, , Japan
Toyama Prefectural Central Hospital, Toyama, , Japan
University of Yamanashi Hospital, Yamanashi, , Japan