The goal of this clinical trials is to test the impact of probiotics on skin hydration in adolescents and young adults with mild acne. The hypothesis of this study is that the probiotic formulation is superior to placebo in improving the skin hydration in adolescents and young adults with minimal acne after 12 weeks of consumption.
This pilot study is a monocentric, randomized, double-blind, placebo-controlled, parallel-arm study. The product allocation will be performed using a dynamic randomization algorithm designed to minimize imbalance between the 2 arms, within the strata defined by 3 factors: age, Global Acne Evaluation (GEA) score and sex. 60 participants (adolescents and adults) with mild acne vulgaris will be recruited for this study, according to the following inclusion and exclusion criteria. There will be a total of 3 study visits: V1 (screening and randomization), V2 (mid-study follow-up), and V3 (end-of-study). The study will last a total of 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
58
Biofortis
Saint-Herblain, France
Corneal hydration after 12 weeks
The primary endpoint of the study is to compare the absolute change of the hydration level of the facial cornea between baseline (visit V1) and visit V3, assessed with Corneometer® CM825 on the forehead expressed in arbitrary units (a.u.) ranging from 0 to 120 (\<30: very dry skin; 30-40: dry skin; \>40: normal hydrated skin).
Time frame: 12 weeks
Corneal hydration of the forehead after 6 weeks
The absolute change of the hydration of the facial cornea measured on the forehead with Corneometer® CM825 (expressed in a.u.) between V1 and V2, ranging from 0 to 120 (\<30: very dry skin; 30-40: dry skin; \>40: normal hydrated skin)).
Time frame: 6 weeks
Transepidermal water loss of forehead skin
The absolute change of the transepidermal water loss (TEWL) measured on the forehead with Tewameter® TM300expressed in g/h/m² (0-10: very healthy; 10-15: healthy; 15-25: normal; 25-30: stretched skin; \>30: critical), between V1 and each visit (V2, V3).
Time frame: 12 weeks
Symptoms of acne on face
The absolute change of acne vulgaris symptoms (face and back) assessed with the Échelle de Cotation des Lésions d'Acné (acne grading scale; ECLA) scale between V1 and each visit (V2, V3), expressed in a.u, ranging from 0 to 5 on the face (0: no lesions; 1: \<5; 2: 5-9; 3: 10-19; 4: 20-40; 5: \> 40 lesions), and ranging from 0 to 3 on the back (0: absent; 1: few; 2: moderate; 3: important).
Time frame: 12 weeks
Sebum levels on face
The absolute change of sebum level (expressed in μg/cm²) measured with Sebumeter® SM815 between V1 and V3, ranging from 0 to 350, on the forehead (\<100: dry skin; 100-220: normal skin; \>220: oily skin).
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Disability caused by acne
The absolute change of disability caused by acne assessed with the Cardiff Acne Disability Index (CADI) score (expressed in a.u., range 0-15) between V1 and each visit (V2, V3).
Time frame: 12 weeks
Impact on quality of life
The absolute change of overall Quality of Life, general health and four quality of life domains (Physical, Psychological, Social Relationships and Environment) assessed with six sub-scores of the World Health Organization Quality of life questionnaire - Brief version (WHOQoL-BREF) (expressed in a.u., item scores range 1-5, transformed scores range 0-100) between V1 and each visit (V2, V3).
Time frame: 12 weeks
Self-assessment of acne level on face and back
The absolute change of self-assessment acne level assessed with a visual analogue scale (VAS, range 0-10) between V1 and each visit (V2, V3).
Time frame: 12 weeks
Self-assessment of treatment satisfaction
The global study product satisfaction assessed with a visual analogue scale VAS (range 0-10) at V2 and V3.
Time frame: 12 weeks