Cosmetics Product EffectsNCT05004103
Cosmetic Products and Facial Skin Microbiome
A study testing Cosmetic products application in people with Cosmetics Product Effects, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cosmetics Product Effects
- What is being tested?
- Cosmetic products application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Mar 2021to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female 18-35 years old
- signed the informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Clinical Research Supporting Unit
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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. .
Read the 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).
- 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.
- 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.
- First follow up: Investigator will check vital signs and facial skin value. Investigational Products will dispensed in this visit for 2 weeks usage.
- 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
- Cosmetics Product Effects
- Being tested
- Cosmetic products application
- Keywords
- Skin Microbiome, Facial Skin Microbiome, MIcrobiome diversity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic products applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Skin microbiome evaluation | Experimental | Female healthy volunteers applied cosmetic products (cleanser and moisturizer cream), the diversity of skin microbiome will be examined before and after using the products Receives: Other: Cosmetic products application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome diversity index
The amount and diversity of microbiota will be observed on facial skin before and after product application
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days
Skin color intensity
The skin color expressed in colorimeter index value. The observation is conducted before and after product application
Measured: 28 dyas
Transepidermal Waterloss (g/h/m2)
The hydration of skin is observed by Tewameter. The observation is conducted before and after product application
Measured: 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
Measured: 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
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start29 Mar 2021
- Primary completion31 May 2021
- Study completion20 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cosmetics Product EffectsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- PT Paragon Technology and Innovation
- Responsible party
- Principal investigator, Prof. dr. Franciscus D. Suyatna, PhD, SpFK, Universitas Indonesia
- Investigators
- Frans Suyatna, Prof, PhD, Principal investigator, Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004103
- Sponsor's protocol ID
- CRSU.P.PTI/11/20/17.02
- Status last verified
- Aug 2021
- First submitted
- 8 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22954074Vijay 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.
PubMed 28761849Wallen-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
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.
PubMed 29332945Ogai 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.
PubMed 30333815Lee 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.
PubMed 29193830
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Cosmetic Products and Its Effects on Facial Skin Microbiome
- ClinicalTrials.gov ID
- NCT05004103
- Acronym / sponsor ID
- CRSU.P.PTI/11/20/17.02
- Conditions
- Cosmetics Product Effects
- Keywords
- Skin Microbiome, Facial Skin Microbiome, MIcrobiome diversity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- PT Paragon Technology and Innovation
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 20 Aug 2021 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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.
- 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.
- First follow up: Investigator will check vital signs and facial skin value. Investigational Products will dispensed in this visit for 2 weeks usage.
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post study
| Arm | Type | Receives |
|---|---|---|
| Skin microbiome evaluation | Experimental | Other: Cosmetic products applicationFemale healthy volunteers applied cosmetic products (cleanser and moisturizer cream), the diversity of skin microbiome will be examined before and after using the products |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female 18-35 years old
- signed the informed consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic products applicationFemale 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. | Other | Skin microbiome evaluation |
Primary outcome
Microbiome diversity index
Time frame: 28 days
The amount and diversity of microbiota will be observed on facial skin before and after product application
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.
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.
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.
Skin color intensity
Time frame: 28 dyas
The skin color expressed in colorimeter index value. The observation is conducted before and after product application
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Background: PubMed 22954074Collins-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.
- Background: PubMed 28761849Vijay 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.
- BackgroundWallen-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
- Results publication: PubMed 29332945Byrd 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.
- Results publication: PubMed 30333815Ogai 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.
- Results publication: PubMed 29193830Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans Suyatna, Prof, PhD principal investigator
Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetic products application in people with Cosmetics Product Effects, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome diversity index (time frame: 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05004103, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.