Cosmetic Products and Facial Skin Microbiome
The Efficacy of Cosmetic Products and Its Effects on Facial Skin Microbiome
1 other identifier
interventional
24
1 country
1
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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
August 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2021
CompletedAugust 13, 2021
August 1, 2021
2 months
July 8, 2021
August 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
Study Arms (1)
Skin microbiome evaluation
EXPERIMENTALFemale healthy volunteers applied cosmetic products (cleanser and moisturizer cream), the diversity of skin microbiome will be examined before and after using the products
Interventions
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.
Eligibility Criteria
You may qualify if:
- female 18-35 years old
- signed the informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indonesia Universitylead
- PT Paragon Technology and Innovationcollaborator
Study Sites (1)
Clinical Research Supporting Unit
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
Related Publications (6)
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.
PMID: 22954074BACKGROUNDVijay 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.
PMID: 28761849BACKGROUNDWallen-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
BACKGROUNDByrd 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.
PMID: 29332945RESULTOgai 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.
PMID: 30333815RESULTLee 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.
PMID: 29193830RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Frans Suyatna, Prof, PhD
Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Pharmacology Professor
Study Record Dates
First Submitted
July 8, 2021
First Posted
August 13, 2021
Study Start
March 29, 2021
Primary Completion
May 31, 2021
Study Completion
August 20, 2021
Last Updated
August 13, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share