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

Acne Vulgaris Clinical Trial

Official title:

Randomized, Double Blind and Placebo-controlled Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878238
• Other study ID #: ACNE_PROB
• Status: Completed
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: May 29, 2019

Study information

• Verified date: July 2019
• Source: Bionou Research, S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 29, 2019
• Est. primary completion date: April 15, 2019
• 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.

• 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.

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Dietary Supplement:
• Probiotic Bths-003
Probiotic with maltodextrin as a carrier.

Other:
• Placebo
Placebo with maltodextrin base.

Locations

Country	Name	City	State
Spain	Hospital Vithas Nisa 9 de Octubre	Valencia

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 GAGS (Global Acne Grading System) index score at 12 weeks	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; 1-18 = Mild; 19-30 = Moderate; 31-38 = Severe; > 38 = Very severe	12-week
Secondary	AGSS (Acne Global Severity Scale) index score	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)	0, 6 and 12-week
Secondary	Number of acne lesions	Number of non-inflammatory, inflammatory and total acne lesions.	0, 6 and 12-week
Secondary	Patient subjective evaluation	Min score (Best) = 6 Max score (Worst) = 30	0, 6 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