Study of secondary disease with maintenance therapy with adapalene 0.1%/benzoyl peroxide 2.5% gel and benzoyl peroxide 2.5% gel for acne vulgaris.

JRCT ID: jRCT1051240122

Registered date:05/09/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Acne vulgaris
• Date of first enrollment: 05/09/2024
• Target sample size: 64
• Study type: Observational

Outcome(s)

• Primary Outcome: Change in hemoglobin and melanin levels in skin at 24 weeks compared to 0 week.

Secondary Outcome

(1)Hemoglobin and melanin levels in skin at 0, 12 and 24 weeks
(2)Changes in the percentage of areas exceeding the hemoglobin value1 in skin in the image analysis range at 0, 12, and 24 weeks
(3)Hemoglobin and melanin levels in skin at 0, 12 and 24 weeks at PIE region selected by dermatologist from images at 0 week.
(4)Total area and number of follicular pores at 0, 12, and 24 weeks.
(5)Skin texture at 0, 12, and 24 weeks

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients in a previous study (jRCTs051200035) had images acquired with the Antera 3D at 0, 12, and 24 weeks.
(2) Patients who were using concomitantly prohibited drugs during the 24-week observation period in a previous study (jRCTs051200035), but were included in the evaluation because they were not considered to affect the analysis of the primary efficacy endpoint.
(3) Patients who are guaranteed the opportunity to refuse, by opt-out, the secondary use of information obtained in a previous study (jRCTs051200035)

Exclude criteria

(1) Patients with an erythema score of 1 or higher on the local irritation assessment in a previous study (jRCTs051200035)
(2) Patients who used concomitantly prohibited drugs during the 24-week observation period in a previous study (jRCTs051200035) and were determined to affect the analysis of the primary efficacy endpoint

Related Information

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