Efficacy and safety of the topical isoflavone product on the facial skin in male participants: a randomized controlled trial

Phase 2

Recruiting

• Conditions: Healthy male participants; Isoflavones; male; skin; face

• Registration Number: TCTR20240312001
• Lead Sponsor: Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-12
• Last Update Posted: 19 August 2024
• Study Completion: 2024-09-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified