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.

An observational study to evaluate the efficacy of maintenance therapy with adapalene 0.1%/benzoyl peroxide 2.5% gel and benzoyl peroxide 2.5% gel on secondary disease in acne vulgaris

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1051240122

Enrollment

Registered

2024-09-05

Start date

2024-09-05

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Change in hemoglobin and melanin levels in skin at 24 weeks compared to 0 week.	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

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Contacts

Public ContactTanizaki Hideaki

Kansai Medical University Hospital

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

Outcome results