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A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients.

A study on the application method for prevention/reduction of the local irritation with the benzoyl peroxide preparations for acne vulgaris patients. - A study for the prevention of local irritation of the BPO preparation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031922
Enrollment
120
Registered
2018-03-27
Start date
2018-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acne vulgaris

Interventions

Gradual increase application group (Epiduo Gel) 20 subjects
BPO preparation use experience. Application once a day consecutive for appropriate amount, 12 weeks Non-gradual increase application group (Epiduo Gel) 20 subjects
BPO preparation use experience. Application once a day consecutive for appropriate amount, 12 weeks Gradual increase application group (BPO Gel) 40 subjects
BPO preparation use experience 20 subjects,no BPO preparation use experience 20 subjects. Application once a day consecutive for appropriate amount, 12 weeks Non-gradual increase application group (BP
BPO preparation use experience 20 subjects,no BPO preparation use experience 20 subjects. Application once a day consecutive for appropriate amount, 12 weeks

Sponsors

NPO Health Institute Research of Skin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Moderate acne vulgaris (6-20 inflammatory rashes on one side of the face) 2) Written consent provided after receiving an explanation of the study content 3) Age >=20 years at the time of obtaining consent.

Exclusion criteria

Exclusion criteria: 1) Treated for acne vulgaris within one month before the study 2) Contraindicated for the investigational drugs 3) Continuous use of nonsteroidal anti-inflammatory drugs (such as ibuprofen) 4) Pregnant or possibly pregnant women, lactating women, and women who wanted to become pregnant during the study period. 5) Judged as ineligible by the physician directing the study 6) Participation in another clinical study or post-marketing surveillance of other drugs for acne vulgaris within six months before the study.

Design outcomes

Primary

MeasureTime frame
A local irritating evaluation (accompanying symptom) during testing period of 12 weeks: Erythema, desquamation, skin drying, itching, irritation / incandescence

Countries

Japan

Contacts

Public ContactYoshitaka Ogaki

EBC&M LLC. Clinical Business Department

yoshitaka_ogaki@ebc-m.com03-6435-3833

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026