Back to resultsFacial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
Primary Purpose
Healthy, Skin Manifestations
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotic with niacin and berry extract
Probiotic without niacin and berry extract
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
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.
Sites / Locations
- Oriflame Cosmetics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Probiotic with niacin and berry extract
Probiotic without niacin and berry extract
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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)
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
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)
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
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
Change from Baseline Antioxidant Level at 8 weeks
Skin feature: Antioxidant level
Site: Temple/Cheek area
Procedure: BioZoom
Unit: Arbitrary unit (AU)
Change from Baseline Microbial Level at 8 weeks
Skin feature: Microbial Level
Site: Forehead
Procedure: Damp cotton swab
Unit: Microbial count by sequencing
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05597254
Brief Title
Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
Official Title
Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oriflame Cosmetics AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Skin Manifestations
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic with niacin and berry extract
Arm Type
Experimental
Arm Title
Probiotic without niacin and berry extract
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic with niacin and berry extract
Intervention Description
1 capsule daily of probiotic with niacin supplementation for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic without niacin and berry extract
Intervention Description
1 capsule daily of probiotic without niacin supplementation for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 capsule daily of placebo supplementation for 8 weeks
Primary Outcome Measure Information:
Title
Change from Baseline Skin Features (pores, wrinkles, colour, pigmentation and redness) at 8 weeks
Description
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
Title
Change from Baseline Skin Features (shininess) at 8 weeks
Description
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
Title
Change from Baseline Skin Features (spot size and color) at 8 weeks
Description
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
Title
Change from Baseline Superficial Hydration at 8 weeks
Description
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
Title
Change from Baseline Skin Barrier Integrity at 8 weeks
Description
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
Title
Change from Baseline Sebum Level at 8 weeks
Description
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
Title
Change from Baseline Antioxidant Level at 8 weeks
Description
Skin feature: Antioxidant level
Site: Temple/Cheek area
Procedure: BioZoom
Unit: Arbitrary unit (AU)
Time Frame
Day 0, Day 56
Title
Change from Baseline Microbial Level at 8 weeks
Description
Skin feature: Microbial Level
Site: Forehead
Procedure: Damp cotton swab
Unit: Microbial count by sequencing
Time Frame
Day 0, Day 56
Secondary Outcome Measure Information:
Title
Questionnaire on general health and wellbeing
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Lee
Organizational Affiliation
Global Senior Nutritional Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oriflame Cosmetics
City
Stockholm
ZIP/Postal Code
11226
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
We'll reach out to this number within 24 hrs