Clinical Trial to Evaluate the Effect of a Probiotic in Acne
NCT ID: NCT04570319
Last Updated: 2023-02-16
Study Results
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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COMPLETED
NA
81 participants
INTERVENTIONAL
2020-04-29
2022-09-20
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic Bths-08
a capsule containing the probiotic blend (nutritional complement)
Probiotic Bths-08
A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks
Placebo
a capsule containing placebo comparator
Placebo
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
Placebo
A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
30 Years
ALL
No
Sponsors
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Bionou Research, S.L.
NETWORK
Responsible Party
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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
Centro Dermatológico Estético de Alicante
Alicante, , Spain
Hospital Universitari Sagrat Cor
Barcelona, , Spain
Clínica Eguren Dermatología y Estética
Madrid, , Spain
Countries
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Other Identifiers
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ACNE.PROBI
Identifier Type: -
Identifier Source: org_study_id
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