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

July 9, 2019 updated by: Bionou Research, S.L.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • Hospital Vithas Nisa 9 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 26 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo with maltodextrin base.
Experimental: Probiotic
Dietary supplement: Probiotic Bths-003
Probiotic with maltodextrin as a carrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in GAGS (Global Acne Grading System) index score at 12 weeks
Time Frame: 12-week

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to treatment
Time Frame: 12-week
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
Time Frame: 12-week
Number of adverse events that occur during the treatment period.
12-week
AGSS (Acne Global Severity Scale) index score
Time Frame: 0, 6 and 12-week

Score between 0 and 5:

0 = Clean = Normal and clear skin without evidence of acne

  1. = Almost clean = There are some non-inflammatory lesions, with uncommon and non-inflamed papules
  2. = Mild = few inflammatory lesions (no nodule-cystic lesions)
  3. = Moderate = Noninflammatory lesions predominate, but multiple inflammatory lesions appear (nodule-cystic lesions may be present)
  4. = Severe = Inflammatory lesions predominate (nodule-cystic lesions may be present)
  5. = Very severe = Highly inflammatory lesions predominate (several nodule-cystic lesions)
0, 6 and 12-week
Number of acne lesions
Time Frame: 0, 6 and 12-week
Number of non-inflammatory, inflammatory and total acne lesions.
0, 6 and 12-week
Patient subjective evaluation
Time Frame: 0, 6 and 12-week
Min score (Best) = 6 Max score (Worst) = 30
0, 6 and 12-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bionou Research, S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2018

Primary Completion (Actual)

April 15, 2019

Study Completion (Actual)

May 29, 2019

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 9, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACNE_PROB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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