A Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne

NCT ID: NCT03878238

Last Updated: 2019-07-10

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2019-05-29

Brief Summary

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A 12-week randomized, double-blind, placebo-controlled pilot study to evaluate the effect of a probiotic blend in the treatment and clinical and subjective evolution of acne vulgaris in adolescent and adult patients between 12 and 30 years.

Detailed Description

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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

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo with maltodextrin base.

Probiotic

Group Type EXPERIMENTAL

Probiotic Bths-003

Intervention Type DIETARY_SUPPLEMENT

Probiotic with maltodextrin as a carrier.

Interventions

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Probiotic Bths-003

Probiotic with maltodextrin as a carrier.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo with maltodextrin base.

Intervention Type OTHER

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.
* Moderate acne according to the AGSS (Acne Global Severity Scale) and / or GAGS (Global Acne Grading System) scales.

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

Locations

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Hospital Vithas Nisa 9 de Octubre

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ACNE_PROB

Identifier Type: -

Identifier Source: org_study_id

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