Clinical Trial to Assess the Efficacy and Safety of a Cosmetic Product in Individuals Showing Signs of Cutaneous Aging.

NCT07343544 | Not Yet Recruiting

• 1 other identifier: AB BIOTICS_2501_COS /SkinMeter
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical study investigates the effects and safety of a topical cosmetic product containing postbiotics (Bifida ferment extract and Pediococcus ferment extract) in women aged 35-60 with visible signs of skin aging. The study is a 3-month, single-center, intra-subject controlled trial involving 45 Caucasian women with sensitive or normal skin. Participants will apply 1 ml of the product twice daily. Clinical evaluations will be conducted at baseline and at 1 month, 2 months, and 3 months, using validated dermatological scales and non-invasive instruments (AEVA3D, Mexameter®, MoistureMap®, Cutometer®, Tewameter®, Clarius®, Glossymeter®). Safety will be assessed through systematic monitoring of adverse events, with serious adverse events expected to remain below 1%. Subjective perception will be evaluated via structured questionnaires.

Conditions

Skin; Skin Ageing; Fine Lines; Face Aging/Photo Aging of Moderate Grade; Face Skin Photoaging

Keywords

Face Skin; Postbiotics; Skin; Skin ageing

Outcome Measures

Primary Outcomes (1)

• Wrinkle Reduction

  Changes in visible signs of skin aging (wrinkles and spots) after 3 months of continuous application. Assess the evolution of wrinkles using AEVA3D-HE2.

  From baseline to the end of treatment at 3 months

Secondary Outcomes (9)

• Spot Depigmentation

  From baseline until the end of treatment at 3 months

• Facial Contour Evolution

  From baseline until the end of treatment at 3 months

• Spot Evolution

  From baseline until the end of treatment at 3 months

• Skin Hydration

  From baseline until the end of treatment at 3 months

• Firmness & Elasticity

  From baseline until the end of treatment at 3 months

Study Arms (1)

Study Arm

OTHER

Open Label Active Product

Other: Active cream

Interventions

Active cream OTHER

Active facial cream with postbiotics.

Study Arm

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants.
• Age between 35 and 60 years.
• All skin types (combination, oily, dry, and/or normal).
• Skin condition: 50% sensitive skin and 50% normal skin.
• Visible signs of facial skin aging (mild/moderate wrinkles and/or pigmentation spots).
• Willingness to participate voluntarily and provide written informed consent.
• Ability to understand the study objectives and procedures.
• Good general health (physical and mental).
• Availability to attend all scheduled visits at the research center.
• Discontinuation of anti-aging products on the experimental area (face) at least 7 days prior to study start.
• Commitment not to change facial hygiene routines during the study.

You may not qualify if:

• Pregnant or breastfeeding women.
• History of allergy to cosmetic products and/or dietary supplements.
• Known allergy or hypersensitivity to any component of the product.
• History or current diagnosis of cancer.
• Active skin diseases or infections in the experimental area.
• Recent or planned surgical or aesthetic interventions in the experimental area Medical-aesthetic treatments on the face within the last 6 months (e.g., botulinum toxin, hyaluronic acid, laser, radiofrequency, HIFU, deep chemical peels, microneedling with actives).
• Relevant dermatological conditions in the experimental area (eczema, psoriasis, allergic/contact dermatitis, etc.).
• Use of topical or systemic medications affecting the skin (retinoids, antibiotics, corticosteroids) within the last 3 months.
• Current or planned use of supplements that may affect skin health (collagen, antioxidant vitamins A/C/E, zinc, omega-3, oral probiotics/prebiotics).
• Systemic diseases such as autoimmune disorders (rheumatoid arthritis, lupus, multiple sclerosis), chronic viral infections (HIV, hepatitis B/C), or severe metabolic diseases.
• Use of any product other than the study product on the experimental area during the study.
• Planned significant changes in health habits during the study (diet, physical activity, structured exercise programs).
• Recent or planned changes in hormonal contraceptives.
• Sun or UVA exposure during the study.
• Participation in another clinical study involving the same experimental area

Sponsors & Collaborators

• AB Biotics, SA: lead
• Dr. Goya Análisis, SL.: collaborator

Study Officials

• Ester Moreno Artero, PhD

  Dr. Goya Análisis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Espadaler, PhD

CONTACT

+34 659055442; espadaler@ab-biotics.com

Nuria Gispets, MSc

CONTACT

+34 607026612; gispets@ab-biotics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share