The First Clinical Trial of Bacteriophage Therapy in Patients wtih Acne Vulgaris

JRCT ID: jRCTs051230164

Registered date:12/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acne Vulgaris
• Date of first enrollment: 03/07/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Topical application of bacteriophage gel on the affected area twice a day for 84 days

Outcome(s)

• Primary Outcome: Number of adverse event

Secondary Outcome

(1) Total number of skin rashes
(2) Number of non-inflammatory skin rashes
(3) Number of inflammatory skin rashes
(4) VAS (subject satisfaction)
(5) Number of times of topical application of the study drug and the amount of topical application

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients diagnosed with acne vulgaris
2)One or more acne vulgaris skin rashes (noninflammatory or inflammatory)
3)12 years old over (Both of male and female)
4)Written informed consent by his or her own will

Exclude criteria

1) Abnormal skin findings (e.g., erosions, ulcers, etc.) at the site of topical application of the study drug that are judged by the principal investigator or subinvestigator to preclude topical application of the study drug
2) Plans for excessive sun exposure or artificial tanning (e.g., esthetic salon)
3) Ineligible to participate in this clinical study due to participation in other clinical trials or clinical studies
4) Has a history of hypersensitivity (e.g., contact dermatitis) to the study drug or its components
5) Pregnant, possibly pregnant or breast feeding and hope to get pregnant during this study
6)The physicians consider that the patients are inappropriate for this study

Related Information

• Primary Sponsor: Tsuruta Daisuke
• Source(s) of Monetary Support: ISKRA INDUSTRY CO., LTD.,Japan Agency for Medical Research and Development