Oriflame Cosmetics
Stockholm, 11226, Sweden
NCT Number: NCT05597254
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Stockholm, 11226, Sweden
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 capsule daily of probiotic with niacin supplementation for 8 weeks
1 capsule daily of probiotic without niacin supplementation for 8 weeks
1 capsule daily of placebo supplementation for 8 weeks
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Day 0, Day 56
Skin feature: Antioxidant level
Site: Temple/Cheek area
Procedure: BioZoom
Unit: Arbitrary unit (AU)
Time frame: Day 0, Day 56
Skin feature: Microbial Level
Site: Forehead
Procedure: Damp cotton swab
Unit: Microbial count by sequencing
Time frame: 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
Oriflame Cosmetics AB
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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