Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

• Sponsor: Oriflame Cosmetics AB (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05597254
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 2.4
• Patients Per Site Per Month: 49.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Skin Manifestations	Dietary Supplement: Probiotic with niacin and berry extract; Dietary Supplement: Probiotic without niacin and berry extract; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
• Actual Study Start Date: Sep 26, 2022
• Anticipated Primary Completion Date: Dec 9, 2022
• Anticipated Study Completion Date: Dec 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic with niacin and berry extract	Dietary Supplement: Probiotic with niacin and berry extract; 1 capsule daily of probiotic with niacin supplementation for 8 weeks
Active Comparator: Probiotic without niacin and berry extract	Dietary Supplement: Probiotic without niacin and berry extract; 1 capsule daily of probiotic without niacin supplementation for 8 weeks
Placebo Comparator: Placebo	Dietary Supplement: Placebo; 1 capsule daily of placebo supplementation for 8 weeks

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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)

3. 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

4. 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)

5. 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

6. 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

7. 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)

8. 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

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oriflame Cosmetics	Stockholm		Sweden	11226

Sponsors and Collaborators

• Oriflame Cosmetics AB

Investigators

• Principal Investigator: Isabella Lee, Global Senior Nutritional Scientist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oriflame Cosmetics AB
• ClinicalTrials.gov Identifier: NCT05597254
• Other Study ID Numbers: 2022-00672-01
• First Posted: Oct 28, 2022
• Last Update Posted: Oct 28, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Manifestations; Niacin; Niacinamide; Nicotinic Acids

Study Results

No Results Posted as of Oct 28, 2022