Cosmetic Products and Facial Skin Microbiome

August 12, 2021 updated by: Prof. dr. Franciscus D. Suyatna, PhD, SpFK, Indonesia University

The Efficacy of Cosmetic Products and Its Effects on Facial Skin Microbiome

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. .

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Clinical Research Supporting Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome diversity index
Time Frame: 28 days
The amount and diversity of microbiota will be observed on facial skin before and after product application
28 days
Facial skin elasticity
Time Frame: 28 days
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
Time Frame: 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.
28 days
Capacity of corneometer unit
Time Frame: 28 days
Corneometer unit reflects the moist index of skin. The corneometer unit observed by Corneometer, before and after product application.
28 days
Skin color intensity
Time Frame: 28 dyas
The skin color expressed in colorimeter index value. The observation is conducted before and after product application
28 dyas
Transepidermal Waterloss (g/h/m2)
Time Frame: 28 days
The hydration of skin is observed by Tewameter. The observation is conducted before and after product application
28 days
pH of facial skin
Time Frame: 28 days
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)
Time Frame: 28 Days
The skin color (MED) is observed using Mexameter and is conducted before and after product application
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

PT Paragon Technology and Innovation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2021

Primary Completion (ACTUAL)

May 31, 2021

Study Completion (ANTICIPATED)

August 20, 2021

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (ACTUAL)

August 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRSU.P.PTI/11/20/17.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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