Cosmetics Product Effects
Conditions
Keywords
Skin Microbiome, Facial Skin Microbiome, MIcrobiome diversity
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.
Interventions
OTHERCosmetic products application
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.
Sponsors
PT Paragon Technology and Innovation
Indonesia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pre-post study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. female 18-35 years old 2. signed the informed consent
Exclusion criteria
1. infected by COVID-19 2. females with skin diseases on face and neck such as atopic dermatitis, skin allergy, acne with moderate and severe degree, seborrheic dermatitis, malignancy 3. females with ongoing skin treatments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Microbiome diversity index | 28 days | The amount and diversity of microbiota will be observed on facial skin before and after product application |
| 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. |
| 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 |
| 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 |
Countries
Indonesia
Outcome results
None listed