Tokyo, Dec. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059939) titled 'Efficacy test of skin care products for sensitive skin' on Dec. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Kao Corporation

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To study the effectiveness of skin care products in improving sensitive skin symptoms. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Apply moisturizer skin care products to the face twice a day for 4wks. Interventions/Control_2 - Apply placebo to the face twice a day for 4wks.

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - 1. Japanese women between 20 and 59 years old. 2. Those who usually use lotion at least 4 days a week. 3. Those whose awareness of facial skin sensitivity is "sensitive" or "somewhat sensitive" out of four levels: "sensitive," "somewhat sensitive," "somewhat not sensitive," or "not sensitive. 4. Those who experience dryness symptoms on the face at least one day a week. 5. Those who have sensitivity symptoms (redness, itching, stinging, tingling, burning) on the face at least one day per week. 6. Those who feel/have felt irritation such as tingling or burning on the face using cosmetics at least one day a week. Key exclusion criteria - 1.Those who are pregnant or may be pregnant, breastfeeding, or less than 6 months postpartum 2.Those who have participated in other studies (all studies using cosmetics, food, pharmaceuticals, quasi-drugs, medical devices, etc.) within the past 4 weeks, or those who have participated in other human studies during the scheduled implementation period of this study. Those who are planning to participate. 3.Those with skin symptoms such as atopic dermatitis or contact dermatitis. 4.Those with a history of allergies or rashes to cosmetics, adhesive tapes, medical tapes, etc. 5.Those with facial skin abnormalities (rash, eczema, wounds, bruises, etc.). 6.Those who have had severe sunburn on their face within the past month 7.Those who are visiting a medical institution due to poor physical condition or skin disease. 8.Those using cosmetics, quasi-drugs, or pharmaceuticals that may affect the test (peels, steroids, anti-inflammatory drugs, topical drugs, antibacterial drugs, etc.). 9.Those with seasonal allergies such as severe hay fever. 10.Those who have regular use of medications (including over-the-counter sleeping pills, anti-allergic medications, pain relievers, hormones, laxatives, intestinal preparations, antibiotics, and medications for other ailments) during the past 3 months. 11.Those who have received cosmetic treatment for the face (laser treatment, collagen injection, etc.). 12.Those who have had aesthetic treatment on their face within the past 1 month 13.Those who use home facial beauty devices or beauty equipment 14.Those who have a habit of smoking. 15.Persons involved in this study. 16.Those who are engaged in a related industry (such as the pharmaceutical industry, cosmetics industry, advertising magazine, etc.) 17.Those who are deemed unsuitable for research participation by the research director due to violation of compliance obligations, etc. 18.Those who use skin care products containing cetyl PG hydroxyethyl palmitamide Target Size - 99

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 24 Day Date of IRB - 2025 Year 10 Month 22 Day Anticipated trial start date - 2025 Year 12 Month 05 Day Last follow-up date - 2026 Year 03 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068555

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