acne vulgaris
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Individuals aged 18 to 39 years at the time of consent acquisition 2) Patients with mild to moderate acne vulgaris 3) Individuals with 10 or more inflammatory lesions on the face, up to approximately 40 lesions. No more than 2 nodules/cysts. Lesion counts on both sides are similar. 4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this study. 5) Individuals who can attend the designated examination date and undergo the examination. 6) Individuals deemed suitable for participation in this study by the principal investigator.
Exclusion criteria
Exclusion criteria: Individuals 1) currently receiving acne treatment with prescription medications from a medical institution. 2) with clinically abnormal facial skin conditions that could affect the objectives of this study. 3) with acne conglobata, acne fulminans, or secondary acne. 4) with underlying conditions or skin symptoms requiring local or systemic therapy that may affect this study. 5) diagnosed with polycystic ovary syndrome (PCOS). 6) with a history of hypersensitivity to ingredients in this trial cosmetic or to cosmetics in general. 7) who changed their facial cleansers or skincare products within the past month. 8) who received, or require, specified medications or therapies during the defined period. A) Topical agents and procedures applied to the study site and head. I. Topical agents i. who used the following products within 4 weeks.: -Formulations containing retinoids -Formulations containing azelaic acid ii. who used the following products within 2 weeks.: -Acne treatments such as antibacterial agents and anti-inflammatory agents -Products containing benzoyl peroxide -Adrenal corticosteroids -Products considered to have a keratolytic effect II. Procedures, etc. i. who received the following procedures within 4 weeks: -Surgery and cosmetic procedures such as chemical peels, laser treatments, phototherapy, or esthetic treatments. B) Systemic medications, etc. I. who used the following products within 12 weeks.: -Preparations containing retinoids II. who used the following products within 4 weeks.: -Other acne treatments -Adrenal corticosteroids -Preparations affecting sex hormones -Traditional Chinese medicine preparations considered effective for acne 9) with severe cardiac, renal, hepatic, respiratory, circulatory, or immunodeficiency conditions that make them unsuitable for the study. 10) who are pregnant, breastfeeding, may be pregnant, or plan to become pregnant during the study. 11) considered unsuitable for the study by the investigator team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Safety 1) Adverse events 2) Side effects 3) Skin findings 4) Subjective symptoms 5) Number of rashes | — |
Secondary
| Measure | Time frame |
|---|---|
| *Skin condition 1) Stratum corneum moisture content 2) Trans epidermal water loss 3) Sebum level 4) Color difference 5) Skin condition score 6) Average pore area, average pore sagging rate 7) Subject self-assessment | — |
Countries
Japan
Contacts
TES Holdings Co., Ltd. Administrative Department of Clinical Trials