An interventional study of Active cream in Skin, Skin Ageing and Fine Lines, sponsored by AB Biotics, SA. Not yet recruiting. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by AB Biotics, SA · Not applicable, Interventional, and Treatment
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.
This clinical study is designed to evaluate the effects and safety of a topical cosmetic product formulated with postbiotic ingredients in adult women presenting visible signs of skin aging. The product contains Bifida ferment extract and Pediococcus ferment extract, selected for their scientifically supported properties in enhancing skin barrier function, reducing oxidative stress, and improving overall skin appearance.
The study is a prospective, single-center, intra-subject controlled clinical trial with a total duration of three months. Forty-five Caucasian women aged between 35 and 60 years will be enrolled. Participants must present mild to moderate facial wrinkles and/or pigmentation spots and will be evenly distributed between sensitive and normal skin types. Inclusion and exclusion criteria are clearly defined to ensure participant safety and data reliability.
Participants will apply 1 ml of the cosmetic product twice daily (morning and evening) to clean, dry facial skin. The study includes four scheduled visits: pre-selection, baseline (T0), (T1), 1 month (T2), 2 months (T3), and 3 months (T4). During these visits, clinical assessments will be conducted using validated dermatological scales (Skin Aging Atlas and Glogau scale) and non-invasive instrumental evaluations.
Instrumental assessments include AEVA3D, Mexameter®, MoistureMap®, Cutometer®, Tewameter®, Clarius®, Glossymeter®.
Photographic documentation will be performed using Visiofaceae, capturing standardized facial images at each visit.
Subjective perception will be evaluated through structured questionnaires administered at T1, T2, T3, and additionally at day 7. These questionnaires assess product appreciation, organoleptic characteristics, absorption, residue, and perceived effects on skin condition.
Safety monitoring includes systematic documentation of all adverse events (AEs). The expected incidence of SAEs related to the product is below 1%. All safety data will be recorded in the Case Report Form (CRF) and analyzed according to Good Clinical Practice (GCP) guidelines. Participants will be compensated for travel and related expenses.
Statistical analysis will be conducted using RStudio software. The study is powered to detect significant changes in skin aging parameters, with a sample size of 45 participants calculated to achieve 80% statistical power. Analysis will include descriptive statistics, repeated measures ANOVA, and mixed model repeated measures (MMRM) to evaluate treatment effects over time.
This study aims to provide robust clinical evidence supporting the efficacy and safety of a novel cosmetic formulation based on postbiotic technology, contributing to the development of innovative anti-aging skincare solutions.
AB Biotics, SA is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open Label Active Product
Other: Active cream
Active facial cream with postbiotics.
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.
Time frame: From baseline to the end of treatment at 3 months
Spot Depigmentation
Evaluate the improvement in facial pigmentation using a clinical scale adapted from the Glogau Scale.
Time frame: From baseline until the end of treatment at 3 months
Facial Contour Evolution
Assess the evolution of contour after 1, 2, and 3 months using AEVA3D-HE2.
Time frame: From baseline until the end of treatment at 3 months
Spot Evolution
Assess the evolution of facial spots after 1, 2, and 3 months using Mexameter® MX 18.
Time frame: From baseline until the end of treatment at 3 months
Skin Hydration
Determine facial hydration after 1, 2, and 3 months using MoistureMap® MM200.
Time frame: From baseline until the end of treatment at 3 months
Firmness & Elasticity
Determine facial firmness and elasticity after 1, 2, and 3 months using Cutometer® MPA 580.
Time frame: From baseline until the end of treatment at 3 months
Barrier Function
Determine facial barrier function after 1, 2, and 3 months using Tewameter® TM 300.
Time frame: From baseline until the end of treatment at 3 months
Dermal Thickness
Changes in dermal thickness using Clarius® ultrasound.
Time frame: From baseline until the end of treatment at 3 months
Skin Radiance
Changes in facial radiance using Skin-Glossymeter® GL200.
Time frame: From baseline until the end of treatment at 3 months
Self-perceived improvement
Changes in self-perceived improvement assessed with subjective question.
Time frame: From baseline until the end of treatment at 3 months
No study locations are listed for this record.
Plan to share: No — Sponsor will evaluated IPD sharing upon request
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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AB Biotics, SA