UMIN-ICDS Clinical Trial

Public title

Evaluation of the usefulness of bakuchiol in patients with acne vulgaris: a multicenter, randomized, double-blind comparative study

Acronym

Comparative study of a bakuchiol-containing serum in patients with acne vulgaris

Scientific Title

Evaluation of the usefulness of bakuchiol in patients with acne vulgaris: a multicenter, randomized, double-blind comparative study

Scientific Title:Acronym

Comparative study of a bakuchiol-containing serum in patients with acne vulgaris

Region

Japan

Condition

Acne vulgaris

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to evaluate the usefulness and safety of an 8-week adjunctive treatment with a bakuchiol-containing cream serum, compared with a control cream serum without bakuchiol, in patients with acne vulgaris who have received topical benzoyl peroxide treatment for two weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change in the Acne and Oily Skin Staging score from baseline to 8 weeks after initiation of the study intervention.
At baseline, the side of the face showing greater severity of pustules and inflammatory erythema will be selected as the evaluation side. The same side will be evaluated throughout the study.
Improvement will be scored according to the number of stages improved from baseline: 0 for no improvement, 1 for a one-stage improvement, 2 for a two-stage improvement, and 3 for a three-stage improvement.
For the primary analysis, the improvement score at Week 8 will be compared between the bakuchiol group and the control group using the Mann-Whitney U test.

Key secondary outcomes

1. Assessment of acne symptoms
Pustules, inflammatory erythema, comedones, scars, and acne severity according to the criteria of the Acne Study Group will be assessed at baseline and at Weeks 2, 4, and 8.
2. Clinical skin findings
Scaling, dryness, and post-inflammatory hyperpigmentation will be assessed at baseline and at Weeks 2, 4, and 8 using a five-point scale from 0 to 4.
3. Subjective symptoms
Skin irritation and subjective dryness will be assessed at baseline and at Weeks 2, 4, and 8 using a five-point scale from 0 to 4.
4. Image-based assessment
Full-face, right-side, and left-side facial images will be obtained using the VISIA imaging system at baseline and at Weeks 2, 4, and 8. Images and analysis parameters generally available from the VISIA system will be assessed as exploratory outcomes.
5. Quality-of-life assessment
Quality of life will be assessed using Skindex-16 at baseline and at Weeks 4 and 8.
6. Cosmetic usability assessment
Participants will complete a questionnaire assessing the usability and sensory characteristics of the study products at baseline and at Weeks 4 and 8.
7. Safety assessment
Adverse events and adverse reactions occurring during the study period will be recorded. At the end of the study, safety will be classified into one of three categories: safe with no adverse reaction, generally safe with an adverse reaction that allows continued use, or a safety concern requiring discontinuation because of an adverse reaction.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Bakuchiol group
Participants will use Collage Repair Soap, Collage Repair Lotion Moist, and Collage Repair Baku Serum DR, a cream serum containing bakuchiol, twice daily in the morning and evening for 8 weeks.
After washing the face, participants will apply the lotion to the entire face, followed by two to three pumps, equivalent to approximately 0.4 to 0.6 g, of the bakuchiol-containing cream serum to the entire face. Topical acne medication, including a benzoyl peroxide preparation, will be applied after the study skincare products.

Interventions/Control_2

Control group
Participants will use Collage Repair Soap, Collage Repair Lotion Moist, and a control cream serum with the same formulation as the bakuchiol-containing serum except for the absence of bakuchiol, twice daily in the morning and evening for 8 weeks.
After washing the face, participants will apply the lotion to the entire face, followed by two to three pumps, equivalent to approximately 0.4 to 0.6 g, of the control cream serum to the entire face. Topical acne medication, including a benzoyl peroxide preparation, will be applied after the study skincare products.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

50

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients must meet all of the following criteria:
1. Aged 18 years or older and younger than 50 years at the time of informed consent.
2. An outpatient with acne vulgaris.
3. Classified as Stage 2 or Stage 3 according to the Acne and Oily Skin Staging system at baseline.
4. Has received topical treatment with a benzoyl peroxide preparation for two weeks before initiation of the study intervention.
5. Is able to discontinue skincare products other than the study products during the study period, except for sunscreen and makeup products.
6. Is able to continue using the same sunscreen and makeup products without changing them during the study period.
7. Is able to attend the scheduled study visits.
8. Is considered eligible for participation by the investigator.
9. Has provided written informed consent to participate in the study.

Key exclusion criteria

Patients meeting any of the following criteria will be excluded:
1. Pregnant, possibly pregnant, or breastfeeding.
2. Has atopic dermatitis, rosacea, or another facial disorder that may affect the treatment or evaluation of acne.
3. Has a history of allergy to cosmetic products.
4. Has undergone a procedure that may affect the study area, such as iontophoresis, within 4 weeks before initiation of the study intervention.
5. Has used cosmetic products intended to improve acne, including products containing vitamin C or glycolic acid, within 4 weeks before initiation of the study intervention.
6. Is currently using another bakuchiol-containing cosmetic product or a retinol-related compound.
7. Is participating in another clinical study.
8. Is considered unsuitable for participation by the investigator for any other reason.

Target sample size

120

Name of lead principal investigator

1st name	Seiko
Middle name
Last name	Kou

Organization

KO CLINIC & Lab

Division name

Director and Chairperson

Zip code

231-0015

Address

8F Kannai ex Building, 4-54 Onoe-cho, Naka-ku, Yokohama, Kanagawa 231-0015, Japan

TEL

045-651-1117

Email

seiko.kou@ko-clinic.jp

Name of contact person

1st name	Satoru
Middle name
Last name	Nakamura

Organization

Mochida Healthcare Co., Ltd.

Division name

Scientific Affairs Department

Zip code

162-8451

Address

PAXX Building, 2-12 Ichigaya-honmura-cho, Shinjuku-ku, Tokyo 162-8451, Japan

TEL

03-5229-3940

Homepage URL

Email

satoru.nakamura@hc.mochida.co.jp

Institute

KO CLINIC & Lab

Institute

Department

Personal name

Organization

Mochida Healthcare Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shiba Palace Clinic Ethics Review Committee

Address

DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN

Tel

03-5408-1599

Email

shiba_palace@s-palace-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

KO CLINIC & Lab（神奈川県）、他11施設

Date of disclosure of the study information

2026

Year

11

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

There is no plan to make de-identified individual participant-level data publicly available.

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

07

Day

Date of IRB

2026

Year

10

Month

15

Day

Anticipated trial start date

2026

Year

11

Month

11

Day

Last follow-up date

2027

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

11

Month

04

Day

Last modified on

2026

Year

11

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072689