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| Name | Class |
|---|---|
| PT Paragon Technology and Innovation | UNKNOWN |
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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. .
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).
All adverse events (AEs) occurred during study will be recorded in Case Report Form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin microbiome evaluation | Experimental | Female healthy volunteers applied cosmetic products (cleanser and moisturizer cream), the diversity of skin microbiome will be examined before and after using the products |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic products application | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Healthy females
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| Name | Affiliation | Role |
|---|---|---|
| Frans Suyatna, Prof, PhD | Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Supporting Unit | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22954074 | Background | Collins-Fulea C, Klima K, Wegienka GR. Prevalence of low vitamin D levels in an urban midwestern obstetric practice. J Midwifery Womens Health. 2012 Sep-Oct;57(5):439-44. doi: 10.1111/j.1542-2011.2012.00167.x. | |
| 28761849 | Background | Vijay A, Gupta S, Rawat S, Jain SK. A Rare Case of Coinfection with White Piedra and Pediculosis Capitis. Indian Dermatol Online J. 2017 Jul-Aug;8(4):279-280. doi: 10.4103/idoj.IDOJ_353_16. No abstract available. |
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Pre-post study
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| 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 |
| Background | Wallen-Russell, C. The Role of Every-Day Cosmetics in Altering the Skin Microbiome: A Study Using Biodiversity. Cosmetics 2019, 6, 2. https://doi.org/10.3390/cosmetics6010002 |
| 29332945 | Result | Byrd AL, Belkaid Y, Segre JA. The human skin microbiome. Nat Rev Microbiol. 2018 Mar;16(3):143-155. doi: 10.1038/nrmicro.2017.157. Epub 2018 Jan 15. |
| 30333815 | Result | Ogai K, Nagase S, Mukai K, Iuchi T, Mori Y, Matsue M, Sugitani K, Sugama J, Okamoto S. A Comparison of Techniques for Collecting Skin Microbiome Samples: Swabbing Versus Tape-Stripping. Front Microbiol. 2018 Oct 2;9:2362. doi: 10.3389/fmicb.2018.02362. eCollection 2018. |
| 29193830 | Result | Lee HJ, Jeong SE, Lee S, Kim S, Han H, Jeon CO. Effects of cosmetics on the skin microbiome of facial cheeks with different hydration levels. Microbiologyopen. 2018 Apr;7(2):e00557. doi: 10.1002/mbo3.557. Epub 2017 Nov 29. |