NCT05813054

Brief Summary

Oral supplement with an HA matrix ingredient composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%) to evaluate the hydration of the stratum corneum of facial skin in healthy women showing natural signs of age-related aging versus placebo

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

August 27, 2024

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

February 17, 2023

Last Update Submit

August 26, 2024

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

  • Skin Moisture

    The changes in the hydration of the facial stratum corneum using the Corneometer® CM825 measuring device, range: 0-130 arbitrary units

    Day 0, 12 week

Secondary Outcomes (15)

  • Skin Moisture

    Day 0, 6 week, 12 week

  • Skin elasticity

    Day 0, 6 week, 12 week

  • Skin hardness

    Day 0, 6 week, 12 week

  • Skin Barrier

    Day 0, 6 week, 12 week

  • Skin pH

    Day 0, 6 week, 12 week

  • +10 more secondary outcomes

Study Arms (2)

HA matrix ingredient

EXPERIMENTAL

1 cap/day

Dietary Supplement: HA matrix ingredient

Placebo

PLACEBO COMPARATOR

1 cap/day

Dietary Supplement: Placebo

Interventions

HA matrix ingredientDIETARY_SUPPLEMENT

1 capsule/day

HA matrix ingredient
PlaceboDIETARY_SUPPLEMENT

1 capsule/day

Placebo

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy women between 35 and 65 years of age (inclusive), showing signs of physiological facial skin aging.
  • Women willing not to use any firming product, skin lightening, or any other topical or systemic medication known to affect skin aging or dyschromia during the study period.
  • Be informed of the nature of the study and give their IC in writing.
  • Women willing not to become pregnant during the course of the study, using contraceptive methods considered highly effective.

You may not qualify if:

  • Women with allergies to the ingredients in the investigational product.
  • Women who have used a dietary or nutricosmetic supplement containing HA, or who have undergone Botox or HA infiltrations, in the last 6 months prior to signing the IC.
  • Women who have undergone:
  • Suspected uncontrolled disease, such as diabetes mellitus (DM), arterial hypertension (HT), hyperthyroidism or hypothyroidism, renal failure or liver failure.
  • Women who do not wish, for whatever reason, to take the supplements in the study.
  • Known pregnancy or lactation.
  • Presence of inflammatory skin disease such as psoriasis, atopic dermatitis, rosacea, acne or hidradenitis suppurativa.
  • Presence of active malignant pathologies or premalignant skin lesions such as actinic keratoses.
  • Psychiatric disorder that is not managed or any other circumstance or pathology that prevents the participant from understanding and/or complying with the study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Related Publications (1)

  • Montero-Vilchez T, Galvez-Martin P, Sanabria-de la Torre R, Cuenca-Barrales C, Molina-Leyva A, Martinez-Puig D, Velasco-Alvarez J, Arias-Santiago S. Oral Supplementation with a New Hyaluronic Acid Matrix Ingredient Improves Skin Brightness, Hydration, Smoothness, and Roughness: Results from a Randomized, Double-Blinded, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2025 Aug;15(8):2099-2116. doi: 10.1007/s13555-025-01447-6. Epub 2025 Jun 11.

    PMID: 40498387DERIVED

Study Officials

  • Salvador Arias

    Hospital Virgen de las Nieves (Granada)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

April 14, 2023

Study Start

October 1, 2022

Primary Completion

March 15, 2023

Study Completion

September 15, 2023

Last Updated

August 27, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)