NCT05842447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

April 24, 2023

Last Update Submit

October 29, 2024

Conditions

Skin Ageing

Keywords

PhotoageingPolyphenolsNatural extractsCollagen metabolismHyaluronic acidOxidative stressAntiglycan effectInflammatory systemIntestinal microbiotaskin microbiota

Outcome Measures

Primary Outcomes (1)

  • Change in skin melanin index.

    Skin melanin index measured by using a Mexameter® MX18.

    At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Secondary Outcomes (37)

  • Change in skin wrinkles.

    At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

  • Change in skin hydratation.

    At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

  • Change in skin elasticity.

    At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

  • Change in skin erythema index.

    At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

  • Change in skin pores.

    At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

  • +32 more secondary outcomes

Study Arms (3)

367 mg Pomanox group

EXPERIMENTAL

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

Dietary Supplement: 367 mg Pomanox group

700 mg Pomanox group

EXPERIMENTAL

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

Dietary Supplement: 700 mg Pomanox group

Control group

PLACEBO COMPARATOR

One capsule daily with maltodextrin for 12 weeks

Dietary Supplement: Control group

Interventions

367 mg Pomanox groupDIETARY_SUPPLEMENT

Treatment with 367 mg Pomanox®P30 during 12 weeks

367 mg Pomanox group
700 mg Pomanox groupDIETARY_SUPPLEMENT

Treatment with 700 mg Pomanox®P30 during 12 weeks

700 mg Pomanox group
Control groupDIETARY_SUPPLEMENT

Treatment with maltodextrin during 12 weeks

Control group

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anna Crescenti

Reus, Catalonia. Spain, 43204, Spain

Location

Eurecat

Reus, 43204, Spain

Location

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Antoni Caimari, PhD

    Fundació Eurecat

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Eurecat's Biotechnology Area

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 6, 2023

Study Start

October 16, 2023

Primary Completion

March 5, 2024

Study Completion

October 28, 2024

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)