Effect of Pomanox® on Skin Ageing (POMASKIN)

NCT ID: NCT05842447

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-10-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

367 mg Pomanox group

One capsule daily with 367 mg of Pomanox®P30 for 12 weeks

Group Type: EXPERIMENTAL

367 mg Pomanox group

Intervention Type: DIETARY_SUPPLEMENT

Treatment with 367 mg Pomanox®P30 during 12 weeks

700 mg Pomanox group

One capsule daily with 700 mg of Pomanox®P30 for 12 weeks

Group Type: EXPERIMENTAL

700 mg Pomanox group

Intervention Type: DIETARY_SUPPLEMENT

Treatment with 700 mg Pomanox®P30 during 12 weeks

Control group

One capsule daily with maltodextrin for 12 weeks

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: DIETARY_SUPPLEMENT

Treatment with maltodextrin during 12 weeks

Interventions

367 mg Pomanox group

Treatment with 367 mg Pomanox®P30 during 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

700 mg Pomanox group

Treatment with 700 mg Pomanox®P30 during 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Control group

Treatment with maltodextrin during 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Women aged 30 years or older and 65 years or less.
• Fitzpatrick skin phototype II-IV.
• Read, write and speak Catalan or Spanish.
• Sign the informed consent.

Exclusion Criteria

• Present any chronic gastrointestinal disease that may interfere with the objectives of the study such as celiac disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome with symptoms in the last 6 months, chronic diarrhea, or having undergone any bariatric surgery procedure.
• Present a chronic disease with clinical manifestation and/or being under pharmacological treatment that may interfere with participation in the study.
• Present values of body mass index ≥ 35 kg/m^2.
• Present a clinical history of active anemia.
• Have consumed or intended to consume during the study treatments, supplements or multivitamin supplements or phytotherapeutic products that interfere with the study treatment (such as retinol or vitamin A, vitamin C, vitamin E, antioxidants, polyphenols, probiotics and prebiotics) up to 30 days before the start of the study intervention.
• Have consumed or intended to consume during the study contraceptive treatments or hormonal therapy up to 30 days before the start of the study intervention.
• Have taken treatment with antibiotics up to 30 days before the start of the study intervention.
• Have taken or intended to take treatments for acne, for photo-ageing or to improve the appearance or condition of the skin (such as chemical peeling, laser therapy, light therapy or hyaluronic acid injection; regular treatment in a facial beauty salon, skin whitening agents) up to 6 months before the start of the study intervention.
• Being a smoker or ex-smoker in the last 6 months before inclusion in the study.
• Consume 2 o more Standard Beverage Units daily or 17 weekly.
• Present allergy and/or intolerance to the study products (such as presenting hypersensitivity to maltodextrin or allergy to pomegranate).
• Being pregnant or intending to become pregnant.
• Being in breastfeeding period.
• Being participating, intending to participate or having participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
• Present any skin disease (such as atopic skin, eczema, neurodermatitis, vitiligo or psoriasis) or any skin disorder in the sudy area (such as irritations, moles, scars or macules).
• Have been intensely exposed to the sun or artificial ultraviolet radiations (solarium) in the test area during the 30 days before the start of the study or planning to do so during the study.
• Not being able to follow the guidelines of the study.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Euromed, S.A.

UNKNOWN

Sponsor Role: collaborator

Fundació Eurecat

OTHER

Sponsor Role: lead

Responsible Party

Antoni Caimari

Director of Eurecat's Biotechnology Area

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoni Caimari, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Eurecat

Locations

Anna Crescenti

Reus, Catalonia. Spain, Spain

Eurecat

Reus, , Spain

Countries

Spain

Related Links

http://eurecat.org

Technological Centre of Nutrition and Health. Eurecat\_Reus.

Other Identifiers

POMASKIN

Identifier Type: -

Identifier Source: org_study_id