A study of the effectiveness of maintenance treatment with adapalene 0.1%-benzoyl peroxide 2.5% gel and benzoyl peroxide 2.5% gel in acne vulgaris patients

The effectiveness of maintenance treatment with adapalene 0.1%-benzoyl peroxide 2.5% gel and benzoyl peroxide 2.5% gel in acne vulgaris patients and the efficacy on acne scar formation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051200035

Enrollment

120

Registered

2020-07-20

Start date

2020-08-31

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

The following 3 groups are assigned on 1:1:1 by the random assignment. The allocation method is dynamic allocation (minimization method). -Adapalene-benzoyl peroxide group -Benzoyl peroxide group -Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with acne vulgaris 2) Patients with 10 or fewer inflammatory lesions on full face due to acute inflammatory treatment within 3 months (12 weeks, allowance; + 1 week) prior to written informed consent 3) Patients with 10 or more and less than 100 atrophic scars (diameter 0.5 mm or more) at informed consent obtained. 4) Patients are 20 years old or more at the time of written consent 5) Patients are written informed consent with participation in this study * Inclusion criteria is regardless of the severity at the first visit and the drug used in the acute inflammation phase.

Exclusion criteria

Exclusion criteria: 1) Patients who are taking Tranilast by oral within 3 months prior to written informed consent 2) Patients with any history of hypersensitivity to adapalene-benzoyl peroxide or benzoyl peroxide components 3) Pregnant or possibly pregnant women, lactating women 4) Women who wanted to become pregnant during the study period 5) Patients judged as ineligible for participation in this study by the investigator 6) Patients participated in another clinical study of other medicine(s) for acne vulgaris within 6 months before written informed consent

Design outcomes

Primary

Measure	Time frame
Treatment success rate (Percentage of patients 10 or fewer inflammatory lesions on full face throughout observation period)	—

Secondary

Measure	Time frame
1) Periods of used externally or oral antibiotics 2) Change in the number of the acne scars 3) Changes in the severity of the acne scars (Global Severity of Atrophic Acne Scar GSAAS) 4) Changes in the Antera 3D parameters (Affected area (mm2) ,Volume (mm3) ,Max depth (mm)) 5) Change in the number of skin rashes (Number of inflammatory lesions, Number of non-inflammatory lesions, Number of total lesions)	—

Measure

Time frame

1) Periods of used externally or oral antibiotics 2) Change in the number of the acne scars 3) Changes in the severity of the acne scars (Global Severity of Atrophic Acne Scar GSAAS) 4) Changes in the Antera 3D parameters (Affected area (mm2) ,Volume (mm3) ,Max depth (mm)) 5) Change in the number of skin rashes (Number of inflammatory lesions, Number of non-inflammatory lesions, Number of total lesions)

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Contacts

Public ContactHideaki Tanizaki

Kansai Medical University Hospital

tanizakh@hirakata.kmu.ac.jp+81-72-804-0101

Outcome results

None listed

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