Cosmetic Products and Facial Skin Microbiome

NCT ID: NCT05004103

Last Updated: 2021-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2021-08-20

Brief Summary

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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. .

Detailed Description

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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.

Conditions

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Cosmetics Product Effects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-post study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Skin microbiome evaluation

Female healthy volunteers applied cosmetic products (cleanser and moisturizer cream), the diversity of skin microbiome will be examined before and after using the products

Group Type EXPERIMENTAL

Cosmetic products application

Intervention Type 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.

Interventions

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Cosmetic 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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PT Paragon Technology and Innovation

UNKNOWN

Sponsor Role collaborator

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. Franciscus D. Suyatna, PhD, SpFK

Clinical Pharmacology Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frans Suyatna, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia

Locations

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Clinical Research Supporting Unit

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 22954074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28761849 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 29332945 (View on PubMed)

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.

Reference Type RESULT
PMID: 30333815 (View on PubMed)

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.

Reference Type RESULT
PMID: 29193830 (View on PubMed)

Other Identifiers

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CRSU.P.PTI/11/20/17.02

Identifier Type: -

Identifier Source: org_study_id

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