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Completed

NCT Number: NCT05597254

Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oriflame Cosmetics

Stockholm, 11226, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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).
  • 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

  • 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 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.

Treatment and study plan

Probiotic with niacin and berry extract

Dietary Supplement

1 capsule daily of probiotic with niacin supplementation for 8 weeks

Probiotic without niacin and berry extract

Dietary Supplement

1 capsule daily of probiotic without niacin supplementation for 8 weeks

Placebo

Dietary Supplement

1 capsule daily of placebo supplementation for 8 weeks

Primary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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)

  8. 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

Secondary outcomes

  1. Questionnaire on general health and wellbeing

    Time frame: Day 0, Day 28, Day 56

    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

Sponsors and collaborators

Lead sponsor

Oriflame Cosmetics AB

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2022
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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