Cosmetic Products and Facial Skin Microbiome

Study Overview
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Brief Summary
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The skin microbiome diversity in female healthy volunteers will be studied along with cosmetic products application in 1 month period. This study is also aimed to investigate the efficacy of cosmetic products on skin rejuvenation. .

Detailed Description
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The study is conducted in COVID-19 pandemic era, thus every person involved in this study must follow health protocol for COVID-19. The study procedure, consist of screening visit (D -7), 7-day wash out, baseline visit (D 0), first follow up ( D 14), and second follow up (D 28). Screening visit: obtained Informed Consent, COVID-19 detection by swab RT-PCR, and inclusion and exclusion criteria, wash out product dispensing, and subject's diary dispensing. Baseline visit: Investigator will check vital signs, facial skin value by Cutometer, Mexameter, Sebumeter, Corneometer, Colorimeter, Tewameter, dan pH meter, and kin taping by Corneofix tape. Investigational Products will dispensed in this visit for 2 weeks usage. First follow up: Investigator will check vital signs and facial skin value. Investigational Products will dispensed in this visit for 2 weeks usage. Second follow up: Investigator will check vital signs, facial skin value, and skin taping by Corneofix tape. All adverse events (AEs) occurred during study will be recorded in Case Report Form.

Official Title
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The Efficacy of Cosmetic Products and Its Effects on Facial Skin Microbiome

Conditions
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Cosmetics Product Effects

Intervention / Treatment
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* Other: Cosmetic products application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female 18-35 years old signed the informed consent Exclusion Criteria: infected by COVID-19 females with skin diseases on face and neck such as atopic dermatitis, skin allergy, acne with moderate and severe degree, seborrheic dermatitis, malignancy females with ongoing skin treatments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-post study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin microbiome evaluation<br>Female healthy volunteers applied cosmetic products (cleanser and moisturizer cream), the diversity of skin microbiome will be examined before and after using the products | Other: Cosmetic products application<br>* Female healthy volunteers applied cosmetic products (cleanser and moisturizer) in the morning and afternoon for 1 month. Seven days wash out period will be conducted prior study starts. The evaluation will be conducted before, two weeks after treatment starts, and at the end of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome diversity index | The amount and diversity of microbiota will be observed on facial skin before and after product application | 28 days | 
| Facial skin elasticity | The ratio between pliability/firmness and expressed in mm. The result before and after product application will be observed by cutometer. | 28 days | 
| Sebum unit of facial skin | Sebumeter unit (mcg/cm2) of facial skin before and after product application will be observed using sebumeter. This sebumeter unit reflects the concentration of sebum on skin per observed area. | 28 days | 
| Capacity of corneometer unit | Corneometer unit reflects the moist index of skin. The corneometer unit observed by Corneometer, before and after product application. | 28 days | 
| Skin color intensity | The skin color expressed in colorimeter index value. The observation is conducted before and after product application | 28 dyas | 
| Transepidermal Waterloss (g/h/m2) | The hydration of skin is observed by Tewameter. The observation is conducted before and after product application | 28 days | 
| pH of facial skin | The pH of facial skin is observed using skin-pH-meter. Observation is conducted before and after product application | 28 days | 
| The skin color related to the Minimal Erythema Dosage (MED) | The skin color (MED) is observed using Mexameter and is conducted before and after product application | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Microbiome, Facial Skin Microbiome, MIcrobiome diversity