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

JRCT ID: jRCTs051200035

Registered date:20/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acne vulgaris
• Date of first enrollment: 31/08/2020
• Target sample size: 120
• Study type: Interventional

Intervention(s)

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
-Control group
The medicines on acute inflammation period are used as the allocation regulator.

Outcome(s)

• Primary Outcome: Treatment success rate (Percentage of patients 10 or fewer inflammatory lesions on full face throughout observation period)

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Tanizaki Hideaki
• Source(s) of Monetary Support: Maruho Co.,Ltd.