Skin Aging
Conditions
Brief summary
The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.
Interventions
DIETARY_SUPPLEMENTPlacebo SoftGel
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
DIETARY_SUPPLEMENTActive SoftGel Supplement
The food supplement active supplement (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
DIETARY_SUPPLEMENTActive Comparator Powder
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water. The food supplement placebo (2 soft gels) will also be consumed once per day with a large glass of water to double-mask the trial.
DIETARY_SUPPLEMENTPlacebo Powder
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
Sponsors
Amazentis SA
MS Clinical Research Pvt. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female trial participants in the age group of 35 -65 years, both ages inclusive. 2. Trial participants in good general health, as determined by the Investigator based on medical history, physical examination, vital signs, and clinical laboratory evaluations (CBC, LFT, and RFT). 3. Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator. 4. Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol. 5. Trial participants must be willing to undergo two minimally invasive skin biopsies collected from the upper arms. 6. Trial participants must be willing to provide blood samples for plasma collection and laboratory Investigations. 7. Trial participants willing to refrain from initiating any new skin care products, oral supplements, or anti-aging treatments during the study. 8. Trial participants willing to maintain their permitted and restricted skincare, diet, and lifestyle habits throughout the study. 9. Trial participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face and upper arms as determined by the dermatologist. 10. Trial participants who agree not to have direct and excessive sun exposure (not more than half an hour daily and during that time use of umbrella to cover face and upper arms). 11. Trial participants willing to refrain from bleaching or any other procedures including facial etc. on face during the study period. 12. Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up. 13. Trial participants willing to abide by and comply with study protocol.
Exclusion criteria
1. Trial participants with known allergy, hypersensitivity, or intolerance to the study products or any of their ingredients, which, in the opinion of the Investigator, may impact participant safety, skin condition, or study outcomes. 2. Trial participants with clinical non-significant laboratory values or clinically significant findings in CBC, LFT, or RFT that, in the opinion of the Investigator, may affect participant safety or study participation. 3. Trial participants with a history or presence of clinically significant systemic diseases, including cardiovascular, immunological, vascular, hepatic, gallbladder, renal, or other uncontrolled medical disorders that, in the opinion of the Investigator, may interfere with study participation or study assessments. 4. Trial participants with active dermatological conditions on the face, including eczema, psoriasis, rosacea, acne, dermatitis, infections, wounds, sunburn, scars, or other skin disorders that may interfere with study assessments. 5. Trial participants who have used anti-aging treatments or procedures, including retinoids, isotretinoin, topical, systemic, injectable, or device-based therapies, within 3 months prior to screening. 6. Trial participants currently taking any medication that, in the opinion of the Investigator, may affect study results or interfere with study participation. 7. Trial participants who have undergone facial cosmetic procedures or aesthetic treatments, including chemical peels, laser treatments, dermabrasion, microneedling, botulinum toxin injections, dermal fillers, or similar procedures within 3 months prior to screening. 8. Trial participants currently using or having used within 1 month prior to screening oral supplements or medications known to influence skin appearance or aging (e.g., collagen supplements, biotin, antioxidant supplements, or investigational products). 9. Trial participants with a history of keloid formation, hypertrophic scarring, poor wound healing, bleeding disorders, or active skin infection, inflammation, wounds, or other abnormal skin conditions at or near the planned biopsy site. 10. Trial participants with a known bleeding disorder or current use of anticoagulant/antiplatelet medications that may interfere with blood collection. 11. Trial participants who have participated in another similar clinical trial within 3 months prior to screening. 12. Female trial participants who are pregnant, breastfeeding, or planning pregnancy during the study period. 13. Trial participants with a history of smoking, current smoking, use of smokeless tobacco products, or a history of or ongoing alcohol or recreational drug abuse. 14. Trial participants who are employees of the Sponsor, Contract Research Organization (CRO), or study site directly involved in the conduct of the study. 15. Trial participants judged by the Investigator to be unsuitable for participation for any reason that may compromise participant safety, protocol compliance, or study integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin aging hallmarks | 8 weeks | Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging) | 8 weeks | To evaluate and compare the efficacy of the test product with baseline and an active comparator in improving facial skin health as assessed with photoimaging (VISIA) |
| changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments. | 8 weeks | — |
| Incidence of adverse events | 8 weeks | — |
Contacts
CONTACTAnurag Singh, MD PhD
CONTACTBrad Currier, PhD
STUDY_DIRECTORDr. Mukta Sachdev, MD
MS Clinical Research Pvt. Ltd
Outcome results
None listed