Cosmetic Products and Facial Skin Microbiome
- Conditions
- Cosmetics Product Effects
- Interventions
- Other: Cosmetic products application
- Registration Number
- NCT05004103
- Lead Sponsor
- Indonesia University
- Brief Summary
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
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).
1. 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.
2. 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.
3. First follow up: Investigator will check vital signs and facial skin value. Investigational Products will dispensed in this visit for 2 weeks usage.
4. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 24
- female 18-35 years old
- signed the informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Skin microbiome evaluation Cosmetic products application Female healthy volunteers applied cosmetic products (cleanser and moisturizer cream), the diversity of skin microbiome will be examined before and after using the products
- Primary Outcome Measures
Name Time Method Facial skin elasticity 28 days The ratio between pliability/firmness and expressed in mm. The result before and after product application will be observed by cutometer.
Skin color intensity 28 dyas The skin color expressed in colorimeter index value. The observation is conducted before and after product application
Transepidermal Waterloss (g/h/m2) 28 days The hydration of skin is observed by Tewameter. The observation is conducted before and after product application
Sebum unit of facial skin 28 days 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.
Capacity of corneometer unit 28 days Corneometer unit reflects the moist index of skin. The corneometer unit observed by Corneometer, before and after product application.
Microbiome diversity index 28 days The amount and diversity of microbiota will be observed on facial skin before and after product application
pH of facial skin 28 days The pH of facial skin is observed using skin-pH-meter. Observation is conducted before and after product application
The skin color related to the Minimal Erythema Dosage (MED) 28 Days The skin color (MED) is observed using Mexameter and is conducted before and after product application
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Supporting Unit
🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia