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

ConditionsSkinSkin AgeingFine LinesFace Aging/Photo Aging of Moderate GradeFace Skin Photoaging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-60
SponsorAB Biotics, SA

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Active cream

    Other intervention

    Active facial cream with postbiotics.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Study ArmOther 1 intervention

Trial outcomes

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.

Time frame
From baseline to the end of treatment at 3 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AB Biotics, SA

Lead sponsor

Dr. Goya Análisis, SL.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: