Jumihaidokuto for acne vulgaris

JRCT ID: jRCTs031220443

Registered date:10/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acne vulgaris
• Date of first enrollment: 13/01/2023
• Target sample size: 120
• Study type: Interventional
• Intervention(s): The enrolled subjects will be randomized to either jumihaidokuto or control group. Both groups will receive oral vibramycin 100 mg/day and clindamycin gel 1% twice daily from the first day of the study. Jumihaidokuto group will also receive Kracie Jumihaidokuto extract fine granules 6.0 g/day. After 2 weeks, vibramycin will be discontinued and the other drugs will be continued until 10 weeks.

Outcome(s)

• Primary Outcome: Change in number of inflammatory rashes before and after treatment (10 weeks after baseline)

Secondary Outcome

1) Number of inflammatory rashes
2) Number of non-inflammatory rashes
3) Total number of rashes
4) Number of rashes with erythema
5) Number of postinflammatory hyperpigmentation
6) Number of postinflammatory erythema
7) IGA score
8) DLQI score
9) Presence or absence of recurrence
10) Premenstrual acne worsening or not
11) Skin oil content: left cheek, forehead
12) Skin moisture content: left cheek, forehead
13) Skin oil/moisture: left cheek, forehead
14) Skin pH: left cheek, forehead

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: < 50age old
• Gender: Both

Include criteria

<Temporary registration>
1) Patients diagnosed with acne vulgaris in the acute inflammatory stage
2) Patients aged 12 to 49 years old (under 15 years old must weigh 45 kg or more) at the time of consent acquisition
3) Patients with 11 to 40 inflammatory rashes on the face (excluding the eye and lip area) in multiple locations at the time of consent acquisition
4) Patients who received sufficient explanation in this study, and obtained written consent from the individual or his/her legal guardian/proxy, based on a full understanding of the study

<Definitive registration>
1) Patients with 11 to 40 inflammatory rashes on the face (excluding the eye and lip area) in multiple locations at the start of the study

Exclude criteria

<Temporary registration>
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 a history of hypersensitivity to any component of the study drug
3) Patients with or with a history of atopic dermatitis, rosacea, rosacea-like dermatitis
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) Participation in other clinical trials within 1 month prior to the start of the study
7) Other subjects deemed inappropriate as research subjects by the principal investigator (or subinvestigator)

<Definitive registration>
1) Patients who have used topical acne medications within 1 weeks prior to the start of the study
2) Patients who used oral antibacterial agents, hormones, vitamins, or Kampo medicines within 1 weeks prior to the start of the study (including treatment for complications)
3) Patients found to be in conflict with the exclusion criteria at the time of temporary registration

Related Information

• Primary Sponsor: Nomoto Mayumi
• Source(s) of Monetary Support: Kracie Pharma, Ltd.