Jumihaidokuto for acne vulgaris

Not Applicable

Recruiting

• Conditions: Acne vulgaris; D000152

• Registration Number: JPRN-jRCTs031220443
• Lead Sponsor: omoto Mayumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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

Exclusion 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 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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in number of inflammatory rashes before and after treatment (10 weeks after baseline)

Secondary Outcome Measures

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