Clinical trial NCT04570319: Clinical Trial to Evaluate the Effect of a Probiotic in Acne
Official title: A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Acne Vulgaris
Keywords: Probiotic
Acne
Microbiome
Microbiota
Symbiotic
Lead sponsor: Bionou Research, S.L.
Sponsor class: NETWORK
First posted: 2020-09-30
Enrollment: 81
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 12-week randomized, multicenter and double-blind, placebo-controlled study to evaluate the effect of a probiotic in the clinical and subjective evolution of acne in adolescent and adult patients.

Detailed description: Acne is a chronic inflammatory disease of the skin that affects 85% of younger adults in westernized populations. Acne pathophysiology is multifactorial and may include alterations of the pilosebaceous unit function, skin microbiota, hormone imbalance and gut microbiota. Acne pathology shares features with inflammatory chronic conditions such as metabolic syndrome, obesity or diabetes.

Probiotics are live microorganisms that when administered in adequate amounts confer a health benefit for the host. Probiotics are proposed for the treatment of inflammatory chronic conditions, including dermatological diseases as atopic dermatitis and psoriasis. However, the clinical evidence is limited. Therefore, usefulness of probiotics for acne vulgaris treatment must be ascertained in humans.

This randomized study aims to evaluate the effect of a probiotic on the treatment and clinical and subjective evolution of acne vulgaris.

Eligibility criteria: Inclusion Criteria:

* Signature of informed consent by the patient (and their legal guardian in case of being under age).
* Age between 12 and 30 years-old.
* AGSS (Acne Global Severity Scale) Score: 2 or higher
* Patients who agree to follow the study's dietary recommendations.

Exclusion Criteria:

* Contraindication of any of the components of the product under study.
* Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
* Consumption of probiotics in the previous 2 months.
* Use of systemic retinoids in the previous 6 months.

Primary outcomes:
measure: Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks
timeFrame: 0 and 12-week
Secondary outcomes:
measure: Change from baseline in the number of acne lesions at week 12
timeFrame: 0 and 12-week
measure: Change from baseline in the GAGS (Global Acne Grading System) index at week 12
timeFrame: 0 and 12-week
measure: Use of antibiotic acne treatment
timeFrame: 12-week
measure: Change from the baseline in the patient subjective evaluation index at week 12
timeFrame: 0 and 12-week
measure: Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome
timeFrame: 0 and 12-week
measure: Adherence to treatment
timeFrame: 12-week
measure: Treatment safety assessed by number of adverse events
timeFrame: 12-week
Other outcomes:
Locations:
city: Guadalupe
country: Spain
facility: Universidad Católica San Antonio de Murcia
state: Murcia
city: Alicante
country: Spain
facility: Centro Dermatológico Estético de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Sagrat Cor
city: Madrid
country: Spain
facility: Clínica Eguren Dermatología y Estética
Study officials:
affiliation: Universidad Católica San Antonio de Murcia (UCAM)
name: Vicente Navarro-Lopez, PhD; MD
role: PRINCIPAL_INVESTIGATOR
References: