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Evaluation of the efficacy and safety of topically applied OC05 cream in improving wrinkles at the outer corners of the eyes.

Evaluation of the efficacy and safety of topically applied OC05 cream (221ISC164) in improving wrinkles at the outer corners of the eyes: randomized, single-blind, left-right comparison study. - Evaluation of the efficacy and safety of topically applied OC05 cream (221ISC164) in improving wrinkles at the outer corners of the eyes: randomized, single-blind, left-right comparison study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050999
Enrollment
15
Registered
2023-07-01
Start date
2022-11-14
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

Healthy adult female

Interventions

The test product, which is dispensed with two pushes, is applied topically twice a day for four weeks. The test product, which is dispensed with two pushes, is applied topically twice a day for four w

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1 Healthy adult females aged 30-60 years. 2 Subjects whose wrinkles at the outer corners of the eyes are judged to be wrinkle grade 2.75-3.75. 3 From the previous paragraphs, subjects with a difference of 0.25 or less between the left and right wrinkle grades will be recruited in the order of the screening test. 4 Subjects with simple skin care habits, such as using only lotion, cream or both 5 Subjects whose written informed consent has been obtained

Exclusion criteria

Exclusion criteria: 1 Subjects with skin conditions that may affect the test results such as urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, or traces of these. 2 Subjects with atopic dermatitis or a past medical history of atopic dermatitis. 3 Subjects who have received or intend to receive aesthetic operations such as Botox, hyaluronic acid or collagen injections, or photofacials during the study period. 4 Subjects who have received or intend to receive skin care treatments at the spa within the last four weeks or during the study period. 5 Subjects who regularly use moisturizers such as cream or all-in-one products and masks, excluding lotion and milky lotion products. 6 Subjects who regularly use cosmetics or ingest foods that are containing vitamin C at the test sites. 7 Subjects who regularly use cosmetics or ingest foods claiming anti-wrinkle efficacy at the test sites. 8 Subjects who have changed or started using a new cosmetic or sunscreen product within the last four weeks. 9 Subjects who have been exposed to ultraviolet light in excess of the dose they could be exposed to on a daily basis, by prolonged outdoor work, exercise, swimming or recreational activities, within the past four weeks, or plan to do so during the test period. 10 Shift workers working on night shifts or rotating day and night shifts. 11 Subjects who are undergoing treatment such as hormone replacement therapy, drug therapy, exercise therapy, diet therapy in a medical institution, or who are diagnosed to require such treatment at the time of obtaining consent. 12 Subjects with past medical history of diseases related to glucose metabolism, lipid metabolism, liver function, renal function, heart function, circulatory system, respiratory system, endocrine system, immune system, nervous system or mental illness. 13 Subjects with a past history of drug or alcohol dependence.

Design outcomes

Primary

MeasureTime frame
Evaluation of wrinkle grade in accordance with JCSS guideline

Secondary

MeasureTime frame
Water content of stratum corneum questionnaire Skin observation by a doctor

Countries

Japan

Contacts

Public ContactSyota Shimizu

Otsuka Pharmaceutical Co., Ltd. Otsu Skin Care Research Institute

Shimizu.Syota@otsuka.jp0775218835

Outcome results

None listed

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