Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

Healthy Clinical Trial

Official title:

Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05597254
• Other study ID #: 2022-00672-01
• Status: Completed
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: December 9, 2022

Study information

• Verified date: April 2023
• Source: Oriflame Cosmetics AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Skin Manifestations

Intervention

Dietary Supplement:
• Probiotic with niacin and berry extract
1 capsule daily of probiotic with niacin supplementation for 8 weeks
• Probiotic without niacin and berry extract
1 capsule daily of probiotic without niacin supplementation for 8 weeks
• Placebo
1 capsule daily of placebo supplementation for 8 weeks

Locations

Country	Name	City	State
Sweden	Oriflame Cosmetics	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Oriflame Cosmetics AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0, Day 56
Primary	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)	Day 0, Day 56
Primary	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	Day 0, Day 56
Primary	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)	Day 0, Day 56
Primary	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	Day 0, Day 56
Primary	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	Day 0, Day 56
Primary	Change from Baseline Antioxidant Level at 8 weeks	Skin feature: Antioxidant level; Site: Temple/Cheek area; Procedure: BioZoom; Unit: Arbitrary unit (AU)	Day 0, Day 56
Primary	Change from Baseline Microbial Level at 8 weeks	Skin feature: Microbial Level; Site: Forehead; Procedure: Damp cotton swab; Unit: Microbial count by sequencing	Day 0, Day 56
Secondary	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	Day 0, Day 28, Day 56