Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

Not Applicable

Completed

• Conditions: Healthy; Skin Manifestations
• Interventions: Dietary Supplement: Probiotic without niacin and berry extract; Dietary Supplement: Probiotic with niacin and berry extract; Dietary Supplement: Placebo

• Registration Number: NCT05597254
• Lead Sponsor: Oriflame Cosmetics AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-26
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-28
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-09
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic without niacin and berry extract	Probiotic without niacin and berry extract	-
Probiotic with niacin and berry extract	Probiotic with niacin and berry extract	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Antioxidant Level at 8 weeks	Day 0, Day 56	Skin feature: Antioxidant level; Site: Temple/Cheek area; Procedure: BioZoom; Unit: Arbitrary unit (AU)
Change from Baseline Skin Features (pores, wrinkles, colour, pigmentation and redness) at 8 weeks	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	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	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	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	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 Microbial Level at 8 weeks	Day 0, Day 56	Skin feature: Microbial Level; Site: Forehead; Procedure: Damp cotton swab; Unit: Microbial count by sequencing
Change from Baseline Sebum Level at 8 weeks	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

Secondary Outcome Measures

Name	Time	Method
Questionnaire on general health and wellbeing	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

Trial Locations

Locations (1)

Oriflame Cosmetics; 🇸🇪 Stockholm, Sweden