Healthy male participants Isoflavones male skin face
Conditions
Interventions
Topical isoflavone product applied 0.3 mL twice daily on the facial skin,Topical product without active ingredients applied 0.3 mL twice daily on the facial skin
Active Comparator Other,Placebo Comparator Other
Topical isoflavone product,Placebo
Sponsors
Chiang Mai University
Eligibility
Sex/Gender
Male
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 45-65 years at the screening visit; 2. Has a body mass index (BMI) of 18-30 kg/m2; 3. Has no reaction to the skin allergy test; and 4. Able to read and write Thai.
Exclusion criteria
Exclusion criteria: 1. Has a treatment with estrogen hormone or isoflavones within 6 months prior to the screening visit; 2. Has a history of periorificial dermatitis, skin cancer or skin cancer on the face, skin infection, and/or serious comorbidities; 3. Has any physical attributes or skin conditions that might interfere with the clear visual (i.e., cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne); 4. Uses a drug(s), herb(s), vitamin(s), mineral(s), or dietary supplement(s) and/or other ingredients regularly in the investigational product that may affect the facial skin within 30 days; 5. Has a history of hypersensitivity to soy products and/or any other ingredients in the investigational product; 6. Uses soy protein isolate, soy protein concentrate, or soy-isoflavone enrichment regularly within 30 days; 7. Uses a topical anti-wrinkle treatment course or any aesthetic cosmetic course within 30 days; 8. Participates in another clinical trial concurrently or within 30 days prior to the screening visit; 9. Has a history of smoking or substance abuse within the past 3 months; and 10. Has a history of alcoholism or consumption of pure alcohol > 35 g/day (5 % alcohol) > 710 mL/day, wine (12 % alcohol) > 296 mL/day, or alcoholic beverages (40% alcohol) > 89 mL/day within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute mean change in skin parameters 0,4,8,12 weeks Non-invasive instruments for skin parameter measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction evaluation 4, 8, 12 weeks Satisfaction questionaire,Adverse events 4, 8, 12 weeks Reporting | — |
Countries
Thailand
Contacts
Public ContactMingkwan Na Takuathung
Faculty of Medicine, Chiang Mai University
Outcome results
None listed