The Impact of Probiotics on Skin Hydration in Youth with Mild Acne

NCT05755256 | Completed Phase 2

• 1 other identifier: L-023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris; Hydration Acne

Keywords

probiotics; acne; adolescents; young adults; skin hydration

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Secondary Outcomes (8)

• Corneal hydration of the forehead after 6 weeks

  6 weeks

• Transepidermal water loss of forehead skin

  12 weeks

• Symptoms of acne on face

  12 weeks

• Sebum levels on face

  12 weeks

• Disability caused by acne

  12 weeks

Other Outcomes (7)

• Skin microbiota composition

  12 weeks

• Quantification of probiotic in stool samples

  12 weeks

• Faecal microbiota composition

  12 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

The product contains the probiotic strain and no other ingredients.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

The control product is a placebo with the same characteristics of appearance and packaging as the tested product.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

After randomization, participants will consume the probiotic for 12 weeks.

Probiotic

Placebo DIETARY_SUPPLEMENT

After randomization, participants will consume the placebo for 12 weeks.

Placebo

Eligibility Criteria

• Age: 15 Months - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 15 and 26 years (limits included),
• Suffering from mild acne vulgaris for at least 1 year (GEA score 1 or 2),
• For women (adolescents and adults) who have started their sexual life: be menstruated and with the same reliable contraception method since at least six months before the beginning of the study and agreeing to keep it during the entire duration of the study. Following contraception methods are allowed: hormonal contraception, intra uterine device, surgical intervention, condoms with spermicides. Contraceptive implants (e.g. Nexplanon®) are not allowed. For women who have not started their sexual life yet, who do not intend to start their sexual life, who do not use a contraception: be menstruated and keep the habits unchanged;
• For women (adolescents and adults): negative urine pregnancy test result;
• Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination;
• Agree to maintain the same skin care regimen throughout the study;
• Able and willing to participate in the study by complying with the protocol procedures, as evidenced by their dated and signed informed consent form. For adolescents (15-17 years): informed consent form signed by the guardians/parents and the individual willing to participate;
• Affiliated with a social security scheme. For adolescents: affiliated with the social security scheme of the guardians/parents;
• Agreeing to be registered on the national file of volunteers in biomedical research file.

You may not qualify if:

• GEA score \<1 or \> 2 (corresponding to the absence of acne or a moderate, severe or very severe acne vulgaris),
• Any disease that affects the secretion of sex hormones,
• Any other dermatological disease (psoriasis, atopic dermatitis, allergy, eczema, etc.);
• Suffering from a metabolic disorder (diabetes, uncontrolled thyroidal condition, uncontrolled arterial hypertension, etc.) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease, etc.) or from a disease found to be inconsistent with the conduct of the study by the investigator;
• Immunodeficiency (immunodeficient and immunocompromised participants, e.g. cancer, HIV, lymphoma, participants on long-term corticosteroid treatment, chemotherapy, and allograft participants);
• Positive COVID-test results within the last 2 weeks and/or currently showing symptoms of COVID-19;
• Use of any systemic antibiotic or oral zinc treatment within 4 weeks prior to randomization, or isotretinoin within 3 months prior to randomization.
• Regular consumption of probiotics, fiber supplements, fermented milk, and/or yogurt containing probiotics within 2 weeks prior to randomization and agreeing not to consume this type of product during the whole study;
• Use of hormone replacement therapy (including oral contraceptives) for less than 6 months;
• Under treatment or dietary supplement which could significantly affect skin microbiota according to the investigator or stopped in a too short period before V1;
• Use of topically applied products (including topical acne drug) that could modulate potential skin improvement within 4 weeks prior to randomization. This includes products with a pH ≥ 8 such as hormone treatments, retinoid and other skin cleansing products, Micellar waters pH ≤ 5 can be used without rubbing the skin too hard with a cotton wool pad in order not to induce a Köbner phenomenon (appearance of new acne lesions on healthy but traumatised skin);
• UVA or UVB exposure in the last 4 weeks or expected exposure during the study (short daily sun exposure is acceptable). The use of a UVA and UVB protection sunscreen factor 50 is mandatory during the study to protect against UVs;
• With a known or suspected food allergy or intolerance or hypersensitivity to ingredient of the study products (yeast);
• Pregnant or lactating women or intending to become pregnant within 3 months ahead;
• With significant change in dietary or physical activity habits in the 3 months before randomization and not agreeing to keep them unchanged throughout the study (hyper or hypocaloric diet, planned start or stop of sports activity in the next 3 months);

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• BioFortis: collaborator

Study Sites (1)

Biofortis

Saint-Herblain, F-44800, France

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Isabelle Metreau, M.D

  BioFortis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 6, 2023
• Study Start: September 4, 2023
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)