A Double-Blind, Randomized, Double-Dummy, Active and Placebo-Controlled Clinical Study to Assess the Effect of an Oral Skin Supplement on Skin Health in Healthy Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Aging
• Intervention / Treatment: Dietary supplement: Placebo SoftGel; Dietary supplement: Placebo Powder; Dietary supplement: Active SoftGel Supplement; Dietary supplement: Active Comparator Powder

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anurag Singh, MD PhD; Phone Number: +41215221274; Email: asingh@timeline.com
• Study Contact Backup: Name: Brad Currier, PhD; Phone Number: +41215221274; Email: bcurrier@timeline.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Food supplement placebo	Dietary supplement: Placebo 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 supplement: Placebo Powder; Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
Active Comparator: Food supplement Active	Dietary supplement: Placebo Powder; Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.; Dietary supplement: Active 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
Sham Comparator: Food supplement Comparator	Dietary supplement: Placebo 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 supplement: Active 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin aging hallmarks	Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events		8 weeks
Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)	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)	8 weeks
changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.		8 weeks

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: MS Clinical Research Pvt. Ltd
• Investigators: Study Director: Dr. Mukta Sachdev, MD, MS Clinical Research Pvt. Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): August 4, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SKIN/TLSS/2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No