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CompletedNCT05597254Updated May 1, 2023

Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

An interventional study of Probiotic with niacin and berry extract and Probiotic without niacin and berry extract in Healthy and Skin Manifestations, sponsored by Oriflame Cosmetics AB. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-01.

Sponsored by Oriflame Cosmetics AB · Not applicable, Interventional, and Basic science

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Phase
Not applicable
Study type
Interventional
Enrollment
109
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
  • Skin Manifestations

Browse trials for

03

In context

Skin Manifestations

29 studies on the registry are indexed under Skin Manifestations; 5 are open to participants now.

This study's enrollment of 109 is above the median of 75 across 23 interventional studies indexed under Skin Manifestations.

Browse Skin Manifestations studies →

Lead sponsor

Oriflame Cosmetics AB is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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).
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Presented health problems or specific medications that could adversely affect the study outcome.
  • Presented any cutaneous 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
109 participants (actual)

Study arms

  • Experimental
    Probiotic with niacin and berry extract

    Dietary Supplement: Probiotic with niacin and berry extract

  • Active comparator
    Probiotic without niacin and berry extract

    Dietary Supplement: Probiotic without niacin and berry extract

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotic with niacin and berry extract

    1 capsule daily of probiotic with niacin supplementation for 8 weeks

  • Dietary supplementProbiotic without niacin and berry extract

    1 capsule daily of probiotic without niacin supplementation for 8 weeks

  • Dietary supplementPlacebo

    1 capsule daily of placebo supplementation for 8 weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0, Day 56

  2. 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)

    Time frame: Day 0, Day 56

  3. 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

    Time frame: Day 0, Day 56

  4. 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)

    Time frame: Day 0, Day 56

  5. 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

    Time frame: Day 0, Day 56

  6. 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

    Time frame: Day 0, Day 56

  7. Change from Baseline Antioxidant Level at 8 weeks

    Skin feature: Antioxidant level Site: Temple/Cheek area Procedure: BioZoom Unit: Arbitrary unit (AU)

    Time frame: Day 0, Day 56

  8. Change from Baseline Microbial Level at 8 weeks

    Skin feature: Microbial Level Site: Forehead Procedure: Damp cotton swab Unit: Microbial count by sequencing

    Time frame: 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

    Time frame: Day 0, Day 28, Day 56

07

Study locations

1 site
  • Oriflame Cosmetics
    Stockholm, 11226, Sweden
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Dec 2022, 2 months.

Of 14 interventional studies with no phase under Skin Manifestations, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 17. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2022
First posted
Oct 28, 2022
StartActual
Sep 26, 2022
Primary completionActual
Dec 9, 2022
CompletionActual
Dec 9, 2022
Last update
May 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05597254
Lead sponsor
Oriflame Cosmetics AB
Responsible party
Sponsor
First posted
Oct 28, 2022
Start date
Sep 26, 2022
Primary completion
Dec 9, 2022
Completion
Dec 9, 2022
Last update
May 1, 2023

Study contacts

Isabella Lee
principal investigator · Global Senior Nutritional Scientist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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