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

Overview

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 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 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 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.
• Dietary supplement Placebo Powder
  Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.

Primary outcome measures

• Skin aging hallmarks [Time frame: 8 weeks]

Secondary outcome measures (3)

• Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging) [Time frame: 8 weeks]
• changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments. [Time frame: 8 weeks]
• Incidence of adverse events [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

• Male and female trial participants in the age group of 35 -65 years, both ages inclusive.
• 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).
• Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator.
• Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol.
• Trial participants must be willing to undergo two minimally invasive skin biopsies collected from the upper arms.
• Trial participants must be willing to provide blood samples for plasma collection and laboratory Investigations.
• Trial participants willing to refrain from initiating any new skin care products, oral supplements, or anti-aging treatments during the study.
• Trial participants willing to maintain their permitted and restricted skincare, diet, and lifestyle habits throughout the study.
• 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.
• 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).
• Trial participants willing to refrain from bleaching or any other procedures including facial etc. on face during the study period.
• Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
• Trial participants willing to abide by and comply with study protocol.

Exclusion criteria

• 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.
• 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.
• 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.
• 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.
• 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.
• Trial participants currently taking any medication that, in the opinion of the Investigator, may affect study results or interfere with study participation.
• 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.
• 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).
• 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.
• Trial participants with a known bleeding disorder or current use of anticoagulant/antiplatelet medications that may interfere with blood collection.
• Trial participants who have participated in another similar clinical trial within 3 months prior to screening.
• Female trial participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
• 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.
• Trial participants who are employees of the Sponsor, Contract Research Organization (CRO), or study site directly involved in the conduct of the study.
• Trial participants judged by the Investigator to be unsuitable for participation for any reason that may compromise participant safety, protocol compliance, or study integrity.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07740824 · SKIN/TLSS/2026-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗