NCT05842447

Effect of Pomanox® on Skin Ageing (POMASKIN)

Effect of Two Doses of Pomanox® Pomegranate Extract Consumption on Skin Ageing. Randomized, Parallel, Placebo Controlled and Triple Blind Clinical Trial (POMASKIN).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Fundació Eurecat · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The state of skin health impacts not only on the general health of individuals, but also on mental health. Ultraviolet radiation (UV) is one of the main external factors that causes skin ageing, producing photo-aging, characterized by multiple alterations in the skin such as the appearance of wrinkles, dryness, erythema, alterations in the pigmentation, inflammation and increased fragility. Several studies show that polyphenols extracts, including pomegranate extracts, have beneficial effects on various skin characteristics induced by photoaging by modulating internal factors that lead to changes associated with photoaging. Among these internal factors are oxidative stress, glycation stress caused by an accumulation of advances glycation end-products (AGEs), inflammation, and the composition of the intestinal and skin microbiota. Pomanox® is a polyphenolic extract derived from pomegranate for which antioxidant activity and positive effects on the metabolism of collagen and hyaluronic acid have been shown in previous in vitro studies.

Detailed description

The hypothesis of the study is that the consumption of Pomanox®P30 will have beneficial effects on skin ageing in humans through the modulation of the metabolism of collagen, hyaluronic acid and the inflammatory system, the inhibition of the production of reactive oxygen species and AGEs, and/or changes in the intestinal and skin microbiota composition. The main objective of the study is to evaluate the effect of consuming two doses of Pomanox®P30 on hyperpigmented skin spots in humans. The secondary objectives of the study are to evaluate the effects of consuming two doses of Pomanox®P30 on other parameters related to skin ageing (wrinkles, elasticity, erythema index, hydration, pores, acne and keratin), on different markers of collagen and hyaluronic acid metabolism, oxidative stress, the anti-glycan effect and the inflammatory system, and on the composition of the intestinal and skin microbiota. A randomized, parallel, placebo-controlled, single-center, triple-blind clinical trial with a 1:1:1 ratio between interventions with 66 participants will be conducted. Each participant will make 4 visits: * A pre-selection visit (to check inclusion/exclusion criteria) (V0), and if the eligibility criteria are met, * 3 study visits during the consumption of the treatments, which will take place on the first day of the study (V1), at 29 days of treatment (V2) and at 85 days of treatment (V3).

Conditions

• Skin Ageing

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	367 mg Pomanox group	Treatment with 367 mg Pomanox®P30 during 12 weeks
DIETARY_SUPPLEMENT	700 mg Pomanox group	Treatment with 700 mg Pomanox®P30 during 12 weeks
DIETARY_SUPPLEMENT	Control group	Treatment with maltodextrin during 12 weeks

Timeline

• Start date: 2023-10-16
• Primary completion: 2024-03-05
• Completion: 2024-10-28
• First posted: 2023-05-06
• Last updated: 2024-10-30

Locations

2 sites across 1 country: Spain