Clinical trial NCT05004103: Cosmetic Products and Facial Skin Microbiome
Official title: The Efficacy of Cosmetic Products and Its Effects on Facial Skin Microbiome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cosmetics Product Effects
Keywords: Skin Microbiome
Facial Skin Microbiome
MIcrobiome diversity
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: PT Paragon Technology and Innovation
First posted: 2021-08-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post study
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Microbiome diversity index
timeFrame: 28 days
measure: Facial skin elasticity
timeFrame: 28 days
measure: Sebum unit of facial skin
timeFrame: 28 days
measure: Capacity of corneometer unit
timeFrame: 28 days
measure: Skin color intensity
timeFrame: 28 dyas
measure: Transepidermal Waterloss (g/h/m2)
timeFrame: 28 days
measure: pH of facial skin
timeFrame: 28 days
measure: The skin color related to the Minimal Erythema Dosage (MED)
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Clinical Research Supporting Unit
state: DKI Jakarta
Study officials:
affiliation: Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
name: Frans Suyatna, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.