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Evaluation of Safety and Skin Condition Following Use of Test Cosmetics

Evaluation of Safety and Skin Condition Following Use of Test Cosmetics - Evaluation of Safety and Skin Condition Following Use of Test Cosmetics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060578
Enrollment
30
Registered
2026-02-04
Start date
2026-02-14
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

Apply the test product to the entire designated side of the face twice daily after washing in the morning and evening. Continue this for 12 weeks. Apply the control product to the entire designated si

Sponsors

TES Holdings Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
*Safety 1) Adverse events 2) Side effects 3) Skin findings 4) Subjective symptoms 5) Number of rashes

Secondary

MeasureTime 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

Public ContactRyoma Shimizu

TES Holdings Co., Ltd. Administrative Department of Clinical Trials

r.shimizu@tes-h.co.jp+81-3-6801-8480

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026