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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05597254
Other study ID # 2022-00672-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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