Clinical Trial to Evaluate the Effect of a Probiotic in Acne

A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris; Acne
• Intervention / Treatment: Dietary supplement: Probiotic Bths-08; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03014
    • Centro Dermatológico Estético de Alicante
  • Barcelona, Spain
    • Hospital Universitari Sagrat Cor
  • Madrid, Spain, 28006
    • Clínica Eguren Dermatología y Estética
  • Murcia
    • Guadalupe, Murcia, Spain, 30107
      • Universidad Católica San Antonio de Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Bths-08; a capsule containing the probiotic blend (nutritional complement)	Dietary supplement: Probiotic Bths-08; A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks
Placebo Comparator: Placebo; a capsule containing placebo comparator	Dietary supplement: Placebo; A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks	Score between 0 and 5: 0: Clean = Normal and clear skin without evidence of acne; Almost clean = There are some non-inflammatory lesions, with uncommon and non-inflamed papules; Mild = few inflammatory lesions (no nodule-cystic lesions); Moderate = Noninflammatory lesions predominate, but multiple inflammatory lesions appear (nodule-cystic lesions may be present); Severe = Inflammatory lesions predominate (nodule-cystic lesions may be present); Very severe = Highly inflammatory lesions predominate (several nodule-cystic lesions) Patients who improve in at least one category of the scale are considered as responders to treatment.	0 and 12-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from the baseline in the patient subjective evaluation index at week 12	Min score (Best) = 6 Max score (Worst) = 30	0 and 12-week
Use of antibiotic acne treatment	Days of antibiotic use for the acne treatment, registered by the patient.	12-week
Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome	Skin sample and genomic and microbiological analysis.	0 and 12-week
Adherence to treatment	Compliance rate (in percentage) calculated as the number of leftover capsules divided by the total number of days between visits.	12-week
Treatment safety assessed by number of adverse events	Number of adverse events that occur during the treatment period.	12-week
Change from baseline in the number of acne lesions at week 12	Number of non-inflammatory, inflammatory and total acne lesions.	0 and 12-week
Change from baseline in the GAGS (Global Acne Grading System) index at week 12	TOTAL SCORE = [Nose S x 1 + Chin S x 1 + Front S x 2 + Right cheek S x 2 + Left cheek S x 2 + Torso S x 3] [Severity (S): 0 = Absence; 1 = Comedones; 2 = Papules; 3 = Pustules; 4 = Nodules] SCORE: 0 = Clean; 1-19 = Mild; 20-30 = Moderate; 31-38 = Severe; > 38 = Very severe Patients who have a reduction in the score of at least 30% are considered as responders to treatment.	0 and 12-week

Collaborators and Investigators

• Sponsor: Bionou Research, S.L.
• Investigators: Principal Investigator: Vicente Navarro-Lopez, PhD; MD, Universidad Católica San Antonio de Murcia (UCAM)

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2020
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Microbiome; Microbiota; Acne; Probiotic; Symbiotic
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: ACNE.PROBI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No