NIPH Clinical Trials Search

BYAKKO-ROSE study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Rosacea
Date of first enrollment	16/06/2025
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	The enrolled subjects will be randomized to either Byakkokaninjinto or control group. Both groups will receive metronidazole gel twice a day for 12 weeks. Byakkokaninjinto group will also receive 6.0g of Kracie Byakkokaninjinto extract fine granules twice a day in divided doses before or between meals for 12 weeks.

Outcome(s)

Primary Outcome

Amount of change in facial hot flashes (NRS) before and after treatment (baseline to 12 weeks)

Secondary Outcome

Evaluate the amount of change before and after treatment (from start of study to 2, 4, 8, 12 weeks). 1) Hot flashes on the face (NRS) 2) Facial skin temperature (quantitative using a thermal imaging camera with image analysis software) 3) Dry mouth (NRS) 4) Dryness of the face (NRS) 5) Erythema severity 6) Facial redness (quantified by image analysis software) 7) Number of inflammatory rashes 8) Skindex-16

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients over 18 years old at the time of consent acquisition 2) Patients diagnosed with rosacea of erythema severity 2 (mild) or higher 3) Patients with hot flashes of NRS 5 (moderate) or higher 4) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on full understanding.
Exclude criteria	1) Patients who have serious heart, liver, renal, pulmonary, hematological, or other diseases that make them unsuitable to participate in the study 2) Patients with organic diseases of the brain and spinal cord (excluding patients with brain and spinal cord tumors) 3) Patients with a history of hypersensitivity to any component of the study drug 4) Patients who are scheduled to undergo chemical peels or laser therapy during the study period 5) Pregnant or possibly pregnant during the study period or breast-feeding 6) Patients who have been taking Kampo medicines within 1 weeks from the start of administration. 7) Patients who have been taking metronidazole gel for skin disease within 1 month from the start of administration. 8) Patients diagnosed with rosacea-like dermatitis (perioral dermatitis, steroid-induced rosacea) at the time of obtaining consent 9) Patients who are participating in another clinical trial or have participated in other clinical trials within 1 month from the time of obtaining consent 10) Other subjects deemed inappropriate as research subjects by the principal investigator (or subinvestigator)