NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1051240122

Registered date:05/09/2024

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.

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedAcne vulgaris
Date of first enrollment05/09/2024
Target sample size64
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeChange 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 maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Tanizaki Hideaki
Address 2-3-1 Shinmachi, Hirakata, Osaka, Japan Osaka Japan 573-1191
Telephone +81-72-804-0101
E-mail tanizakh@hirakata.kmu.ac.jp
Affiliation Kansai Medical University Hospital
Scientific contact
Name Tanizaki Hideaki
Address 2-3-1 Shinmachi, Hirakata, Osaka, Japan Osaka Japan 573-1191
Telephone +81-72-804-0101
E-mail tanizakh@hirakata.kmu.ac.jp
Affiliation Kansai Medical University Hospital