None listed
Conditions
Interventions
Intervention1: 0.5% Bakuchiol Milky Lotion: Twice daily - Morning & Night (before sleep) for 8 weeks for the entire face.
Control Intervention1: nil: NA
Sponsors
Ichimaru Pharcos Co Ltd.,
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult female participants in general good health, as determined by medical history, general physical examination, and dermatological assessment. Female participants aged 25 to 50 years (both inclusive) at the time of screening. Presence of at least two clearly defined dark spots (including post-inflammatory hyperpigmentation, acne spots, or age spots) on each side of the face. Presence of visible fine lines and wrinkles, as assessed by the dermatologist. Presence of under-eye dark circles and visible facial pores, as assessed by the investigator. Participants with Fitzpatrick skin phototypes I II at the Slovakia site and III IV at the India site, enrolled as per predefined site-wise allocation. Participants free from excessive facial hair and without active acne, cuts, abrasions, fissures, wounds, lacerations, or any other active dermatological condition on the face, as determined by the investigator. Participants willing to refrain from using any facial skincare products, treatments, or home remedies other than the provided test product for the duration of the study. Participants willing to avoid cosmetic or dermatological procedures such as bleaching, facials, chemical peels, laser treatments, or similar procedures on the face during the study period. Participants willing to avoid excessive sun exposure (defined as more than 30 minutes per day) and to use physical sun protection (e.g., umbrella or hat) during unavoidable exposure. Participants willing to provide written informed consent, photography consent, and comply with all study visits and protocol requirements. Participants who are willing and able to comply with the study protocol and investigator instructions.
Exclusion criteria
Exclusion criteria: Presence of any clinically significant local skin irritation, dermatological disease, or active facial skin condition that may interfere with study evaluations. Use of any systemic or topical medication, including dietary or food supplements, within 1 month prior to screening, that may affect study outcomes, as determined by the investigator. History or presence of any clinically significant systemic disease, chronic illness, or major surgery within the past 1 year. Unwillingness to remove facial jewellery (e.g., earrings, nose ring, necklace) during VISIA-CR imaging procedures. Hairstyles covering a substantial portion of the forehead that cannot be adjusted for imaging assessments. Ongoing dermatological treatment involving the face at the time of screening or during the study period. Inability or unwillingness to maintain consistent routine use of personal cleanser, makeup, or sunscreen without changes during the study period. Participants with daily sunscreen use or daily/full makeup application will be excluded. Known hypersensitivity or allergy to cosmetic products, cleansing agents, creams, lotions, metals, artificial jewellery, or any ingredient of the test product. Pregnant or lactating participants (self-reported). Participation in any clinical, cosmetic, or investigational study within 1 month prior to screening. History of facial skin allergy, atopic dermatitis, psoriasis, or other chronic inflammatory skin conditions involving the face. Employees of the sponsor, contract research organization (CRO), or study site staff directly involved in the conduct of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in fine lines and wrinkles, under-eye dark circles, dark spots, skin texture, and pores, as assessed by dermatological visual evaluation and instrumental measurements. Assessment of dermatological safety and skin tolerability of the test product throughout the 8-week study duration. Timepoint: Day 0, Weeks 2, 4, and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fine lines and wrinkles, under-eye dark circles, dark spots, skin texture, and pores, as evaluated by trial participant self-assessmentTimepoint: Day 0,Weeks 2, 4, and 8 | — |
Countries
India, Slovakia
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd
Outcome results
None listed