Clinical trial NCT05597254: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Skin Manifestations
Lead sponsor: Oriflame Cosmetics AB
Sponsor class: INDUSTRY
First posted: 2022-10-28
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change from Baseline Skin Features (pores, wrinkles, colour, pigmentation and redness) at 8 weeks
timeFrame: Day 0, Day 56
measure: Change from Baseline Skin Features (shininess) at 8 weeks
timeFrame: Day 0, Day 56
measure: Change from Baseline Skin Features (spot size and color) at 8 weeks
timeFrame: Day 0, Day 56
measure: Change from Baseline Superficial Hydration at 8 weeks
timeFrame: Day 0, Day 56
measure: Change from Baseline Skin Barrier Integrity at 8 weeks
timeFrame: Day 0, Day 56
measure: Change from Baseline Sebum Level at 8 weeks
timeFrame: Day 0, Day 56
measure: Change from Baseline Antioxidant Level at 8 weeks
timeFrame: Day 0, Day 56
measure: Change from Baseline Microbial Level at 8 weeks
timeFrame: Day 0, Day 56
Secondary outcomes:
measure: Questionnaire on general health and wellbeing
timeFrame: Day 0, Day 28, Day 56
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Oriflame Cosmetics
Study officials:
affiliation: Global Senior Nutritional Scientist
name: Isabella Lee
role: PRINCIPAL_INVESTIGATOR
References: