HealthyNCT05597254

Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

A study testing Probiotic with niacin and berry extract and Probiotic without niacin and berry extract in people with Healthy and Skin Manifestations, run by Oriflame Cosmetics AB at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Skin Manifestations
What is being tested?: Probiotic with niacin and berry extract and Probiotic without niacin and berry extract
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 109 participants
Where: 1 siteSweden
Study dates: 26 Sep 2022to 9 Dec 2022
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy volunteers
Fully informed with the study specifications.
Signed consent form prior to commencing the study.
Motivated for participation in the study, and available over the full test period.
Healthy skin on the face (i.e., absence of psoriasis, eczemas, erythema, oedema, scars, wounds, lesions, or any other type of inflammatory or autoimmune skin condition).
Healthy gut (i.e., absence of irritable bowel diseases (IBD), irritable bowel syndrome (IBS), or any other type of inflammatory or autoimmune gut condition).

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No supplementation with probiotic, prebiotic or synbiotic products 2 weeks prior and/or during the whole study period.
No supplementation with niacin (vitamin B3) 2 weeks prior and/or during the whole study period.
No significant change in skin care routine (such as injectable cosmetics, skin tanning, etc.) throughout the whole study period.
No significant change in the diet throughout the whole study period.

Who cannot join

Not fulfilling the inclusion criteria.
Pregnant or lactating 3 months prior to study commencement or during the study.
Women post menopause.
Use of antibiotics at least 4 weeks prior and/or during the whole study period.
Sun-tanned facial skin.
Participating in another clinical study that could interfere with the present research.

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Presented health problems or specific medications that could adversely affect the study outcome.
Presented any cutaneous hypersensitivity or allergy to cosmetic products.
Major surgery on the face one year prior to study commencement.
Applied any cleansing, topical or moisturizing product (including all make-up products) to the measurement area the morning of assessments at Oriflame Cosmetic AB.
Exposure to artificial UV light and/or to the sun during the study.
Special diets (vegan, low carbohydrate, weight loss diet, etc.).
Significant change in weight one month before or during the study period.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Oriflame Cosmetics
Stockholm, 11226

Other trials in Sweden

About this study

The goal of this double-blind randomized clinical trial is to investigate the effects on the skin from oral intake of probiotic supplements in healthy adult men and women. The main questions it aims to answer are: • Will probiotic supplementation result in beneficial changes to different skin parameters? • Will probiotic supplementation result in alterations in the skin microbiome? Participants will consume the study product daily for 8 weeks and come in for skin measurements at baseline and after 8 weeks.

Conditions: Healthy, Skin Manifestations
Being tested: Probiotic with niacin and berry extract, Probiotic without niacin and berry extract, Placebo
Medical subject headings: Skin Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Probiotic with niacin and berry extractDietary supplement
1 capsule daily of probiotic with niacin supplementation for 8 weeks
Probiotic without niacin and berry extractDietary supplement
1 capsule daily of probiotic without niacin supplementation for 8 weeks
PlaceboDietary supplement
1 capsule daily of placebo supplementation for 8 weeks

Study groups in NCT05597254
Study group	Role	What they receive
Probiotic with niacin and berry extract	Experimental	Not described Receives: Dietary Supplement: Probiotic with niacin and berry extract
Probiotic without niacin and berry extract	Active comparator	Not described Receives: Dietary Supplement: Probiotic without niacin and berry extract
Placebo	Placebo comparator	Not described Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Skin Features (pores, wrinkles, colour, pigmentation and redness) at 8 weeks
Skin features: Pores, wrinkles, colour, pigmentation and redness
Site: Cheek, Temple and Forehead - 3 measurement per area. Thus 9 in total.
Procedure: As per WI091 Standard use of the Miravex Antera 3D Camera V1 and TM089 Skin features measurements Using the Antera 3D V1
Unit:
Pores: volume (mm3), index, count, volume/count Wrinkles: overall size, depth (mm), width (mm), Texture: Average Roughness (Ra) Colour variation: DeltaE Pigmentation/redness: average level (concentration per unit area), color variation.
Measured: Day 0, Day 56
Change from Baseline Skin Features (shininess) at 8 weeks
Skin features: Shininess
Site: Entire face
Procedure: As per WI044 Standard use of the VISIA-CR2.2 V3 and TM066 Determination Of Skin Brightness Using The Image Pro Plus Shine Macro Test V2
Unit: Arbitrary unit (AU)
Measured: Day 0, Day 56
Change from Baseline Skin Features (spot size and color) at 8 weeks
Skin features: Spot size and color
Site: Entire face
Procedure: As per WI044 Standard use of the VISIA-CR2.2 V3 and TM038 Clinical Determination of Spot Size and Colour
Unit:
Color = L*a*b*, Delta E Spot size: volume, count
Measured: Day 0, Day 56
Change from Baseline Superficial Hydration at 8 weeks
Skin feature: Superficial hydration
Site: Upper cheek - triplicate measurements
Procedure: As per WI003 Standard use of the Corneometer CM 825 to measure skin moisture V4.
Unit: Arbitrary unit (AU)
Measured: Day 0, Day 56
Change from Baseline Skin Barrier Integrity at 8 weeks
Skin feature: Skin barrier integrity
Site: Upper cheek - single measurement
Procedure: As per WI094 Standard Use of the Delfin Vapometer for Skin Barrier Measurements V1.
Unit: g/m2h
Measured: Day 0, Day 56
Change from Baseline Sebum Level at 8 weeks
Skin feature: Sebum level
Site: Forehead - triplicate measurements
Procedure: As per WI005 Standard use of the Sebumeter SM 815 \& MPA 5 to Measure Skin Sebum Levels V2.
Unit: µg/cm2
Measured: Day 0, Day 56
Change from Baseline Antioxidant Level at 8 weeks
Skin feature: Antioxidant level
Site: Temple/Cheek area
Procedure: BioZoom
Unit: Arbitrary unit (AU)
Measured: Day 0, Day 56
Change from Baseline Microbial Level at 8 weeks
Skin feature: Microbial Level
Site: Forehead
Procedure: Damp cotton swab
Unit: Microbial count by sequencing
Measured: Day 0, Day 56

Secondary outcomes (1)

Questionnaire on general health and wellbeing
Subjective measurements of self-rated health aspects using a 9-point hedonic scale (extremely good to extremely bad) at baseline, mid and end of study to access intervention effects
Measured: Day 0, Day 28, Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 20229 Dec 2022

First posted28 Oct 2022
Study start26 Sep 2022
Primary completion9 Dec 2022
Study completion9 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05597254
Sponsor's protocol ID: 2022-00672-01
Status last verified: Apr 2023
First submitted: 11 Oct 2022
Last updated: 1 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
ClinicalTrials.gov ID: NCT05597254
Acronym / sponsor ID: 2022-00672-01
Conditions: Healthy, Skin Manifestations
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Oriflame Cosmetics ABIndustry (pharma, biotech, devices)
Study start: 26 Sep 2022 (actual)
Primary completion: 9 Dec 2022 (actual)
Study completion: 9 Dec 2022 (actual)
First posted: 28 Oct 2022 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Probiotic with niacin and berry extract	Experimental	Dietary Supplement: Probiotic with niacin and berry extract
Probiotic without niacin and berry extract	Active comparator	Dietary Supplement: Probiotic without niacin and berry extract
Placebo	Placebo comparator	Dietary Supplement: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Healthy volunteers
Fully informed with the study specifications.
Signed consent form prior to commencing the study.
Motivated for participation in the study, and available over the full test period.
Healthy skin on the face (i.e., absence of psoriasis, eczemas, erythema, oedema, scars, wounds, lesions, or any other type of inflammatory or autoimmune skin condition).

Key exclusion criteria (13 listed)

Not fulfilling the inclusion criteria.
Pregnant or lactating 3 months prior to study commencement or during the study.
Women post menopause.
Use of antibiotics at least 4 weeks prior and/or during the whole study period.
Sun-tanned facial skin.

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
Probiotic with niacin and berry extract1 capsule daily of probiotic with niacin supplementation for 8 weeks	Dietary supplement	Probiotic with niacin and berry extract
Probiotic without niacin and berry extract1 capsule daily of probiotic without niacin supplementation for 8 weeks	Dietary supplement	Probiotic without niacin and berry extract
Placebo1 capsule daily of placebo supplementation for 8 weeks	Dietary supplement	Placebo

Primary outcome

Change from Baseline Skin Features (pores, wrinkles, colour, pigmentation and redness) at 8 weeks
Time frame: Day 0, Day 56
Skin features: Pores, wrinkles, colour, pigmentation and redness Site: Cheek, Temple and Forehead - 3 measurement per area. Thus 9 in total. Procedure: As per WI091 Standard use of the Miravex Antera 3D Camera V1 and TM089 Skin features measurements Using the Antera 3D V1 Unit: Pores: volume (mm3), index, count, volume/count Wrinkles: overall size, depth (mm), width (mm), Texture: Average Roughness (Ra) Colour variation: DeltaE Pigmentation/redness: average level (concentration per unit area), color variation.
Change from Baseline Skin Features (shininess) at 8 weeks
Time frame: Day 0, Day 56
Skin features: Shininess Site: Entire face Procedure: As per WI044 Standard use of the VISIA-CR2.2 V3 and TM066 Determination Of Skin Brightness Using The Image Pro Plus Shine Macro Test V2 Unit: Arbitrary unit (AU)
Change from Baseline Skin Features (spot size and color) at 8 weeks
Time frame: Day 0, Day 56
Skin features: Spot size and color Site: Entire face Procedure: As per WI044 Standard use of the VISIA-CR2.2 V3 and TM038 Clinical Determination of Spot Size and Colour Unit: Color = L*a*b*, Delta E Spot size: volume, count
Change from Baseline Superficial Hydration at 8 weeks
Time frame: Day 0, Day 56
Skin feature: Superficial hydration Site: Upper cheek - triplicate measurements Procedure: As per WI003 Standard use of the Corneometer CM 825 to measure skin moisture V4. Unit: Arbitrary unit (AU)
Change from Baseline Skin Barrier Integrity at 8 weeks
Time frame: Day 0, Day 56
Skin feature: Skin barrier integrity Site: Upper cheek - single measurement Procedure: As per WI094 Standard Use of the Delfin Vapometer for Skin Barrier Measurements V1. Unit: g/m2h
Change from Baseline Sebum Level at 8 weeks
Time frame: Day 0, Day 56
Skin feature: Sebum level Site: Forehead - triplicate measurements Procedure: As per WI005 Standard use of the Sebumeter SM 815 \& MPA 5 to Measure Skin Sebum Levels V2. Unit: µg/cm2
Change from Baseline Antioxidant Level at 8 weeks
Time frame: Day 0, Day 56
Skin feature: Antioxidant level Site: Temple/Cheek area Procedure: BioZoom Unit: Arbitrary unit (AU)
Change from Baseline Microbial Level at 8 weeks
Time frame: Day 0, Day 56
Skin feature: Microbial Level Site: Forehead Procedure: Damp cotton swab Unit: Microbial count by sequencing

1 secondary outcome

Questionnaire on general health and wellbeing
Time frame: Day 0, Day 28, Day 56

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.

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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
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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.

Isabella Lee principal investigator

Global Senior Nutritional Scientist

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 13 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: finished, as of the sponsor's last update on 1 May 2023. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline Skin Features (pores, wrinkles, colour, pigmentation and redness) at 8 weeks (time frame: Day 0, Day 56). 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 NCT05597254.

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 1 May 2023.