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NCT07343544

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

Sponsor: AB Biotics, SA

View on ClinicalTrials.gov

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.

Official title: Estudio clínico Para Evaluar Los Efectos y la Seguridad de un Producto cosmético en Sujetos Con Signos de Envejecimiento cutáneo.

Key Details

Gender

FEMALE

Age Range

35 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02

Completion Date

2026-05

Last Updated

2026-01-15

Healthy Volunteers

Yes

Conditions

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

Interventions

OTHER

Active cream

Active facial cream with postbiotics.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Application of any product on the experimental area on the day of study initiation. * Any medical condition, at the investigator's discretion, that may interfere with protocol adherence or participant safety.