Clinical Trial to Evaluate the Effect of a Probiotic in Acne

NCT ID: NCT04570319

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-29

Study Completion Date

2022-09-20

Brief Summary

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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

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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.

Conditions

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Acne Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotic Bths-08

a capsule containing the probiotic blend (nutritional complement)

Group Type EXPERIMENTAL

Probiotic Bths-08

Intervention Type DIETARY_SUPPLEMENT

A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks

Placebo

a capsule containing placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks

Interventions

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Probiotic Bths-08

A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bionou Research, S.L.

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vicente Navarro-Lopez, PhD; MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio de Murcia (UCAM)

Locations

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Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, Spain

Site Status

Centro Dermatológico Estético de Alicante

Alicante, , Spain

Site Status

Hospital Universitari Sagrat Cor

Barcelona, , Spain

Site Status

Clínica Eguren Dermatología y Estética

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ACNE.PROBI

Identifier Type: -

Identifier Source: org_study_id

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