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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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