None listed
Conditions
Interventions
Apply the topical agent (BH318) to the shins twice daily for 4 weeks.
Apply placebo to the shins twice daily for 4 weeks.
Sponsors
Kao Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Japanese women aged 40-69 years 2.Person with dry skin on the shins exhibiting pityriasis like (bran like) scaling. 3.Person who understands the study procedures and schedule and who is willing and able to comply with the restrictions during the study participation period and to follow instructions from the study staff.
Exclusion criteria
Exclusion criteria: 1. Person with eczema, excoriation (scratch marks), contusions (bruises), or other skin lesions at the test site. 2. Person with marked pruritus and erythema at the test site. 3. Person diagnosed with skin diseases affecting the test site (e.g.,atopic dermatitis or asteatotic dermatitis) who has received outpatient treatment or used medication for those conditions within the past year. 4. Person who develops eczema or urticaria in response to heat exposure. 5. Person who has undergone cosmetic/aesthetic procedures at the test site (e.g., esthetic treatments, hair removal, laser therapy) within the past year. 6. Person who is on chronic medication use (e.g., hypnotics, antihistamines, analgesics, hormonal agents, laxatives, acid-suppressing drugs) or who regularly uses other medications for underlying diseases. 7. Person receiving treatment for conditions that may affect blood-flow measurements (e.g., hypertension, heart disease, diabetes, Raynaud's phenomenon, rosacea, telangiectasia). 8. Person who is regularly dieting for weight loss or whose dietary habits are severely irregular. 9. Person with severe sunburn at the test site, or who cannot avoid prolonged outdoor work or sports with the test site exposed. 10. Person who smokes or who habitually consumes excessive amounts of alcohol. 11. Person who is pregnant, breastfeeding, or intends to become pregnant during the study period. 12. Person who, personally or whose family members, are employed in the following fields: cosmetics industry, mass media, research organizations, or clinical trial institutions. 13. Person who has participated in a human clinical study within the past 4 weeks. 14. Person who is currently participating in another clinical trial or who plans to participate in another clinical trial during the study period. 15. Person judged by the principal investigator or study director to be ineligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in physician-assessed desquamation and scaling scores (by visual inspection) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Stratum corneum hydration - Trans epidermal water loss (TEWL) | — |
Countries
Japan
Contacts
Public ContactRyoko Harada
Kao Corporation Skin Care Products Research
Outcome results
None listed