Clinical Trial to Evaluate the Effect of a Probiotic in Acne

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570319
• Other study ID #: ACNE.PROBI
• Status: Completed
• Phase: N/A
• Start date: April 29, 2020
• Est. completion date: September 20, 2022

Study information

• Verified date: February 2023
• Source: Bionou Research, S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 20, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Spain	Centro Dermatológico Estético de Alicante	Alicante
Spain	Hospital Universitari Sagrat Cor	Barcelona
Spain	Universidad Católica San Antonio de Murcia	Guadalupe	Murcia
Spain	Clínica Eguren Dermatología y Estética	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Bionou Research, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Use of antibiotic acne treatment	Days of antibiotic use for the acne treatment, registered by the patient.	12-week
Secondary	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
Secondary	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
Secondary	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
Secondary	Treatment safety assessed by number of adverse events	Number of adverse events that occur during the treatment period.	12-week