NCT03878238

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

March 14, 2019

Last Update Submit

July 9, 2019

Conditions

AcneAcne Vulgaris

Keywords

Probiotic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • AGSS (Acne Global Severity Scale) index score

    0, 6 and 12-week

  • Number of acne lesions

    0, 6 and 12-week

  • Patient subjective evaluation

    0, 6 and 12-week

  • Adherence to treatment

    12-week

  • Treatment safety assessed by number of adverse events

    12-week

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Probiotic

EXPERIMENTAL
Dietary Supplement: Probiotic Bths-003

Interventions

Probiotic Bths-003DIETARY_SUPPLEMENT

Probiotic with maltodextrin as a carrier.

Probiotic
PlaceboOTHER

Placebo with maltodextrin base.

Placebo

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vithas Nisa 9 de Octubre

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 18, 2019

Study Start

July 11, 2018

Primary Completion

April 15, 2019

Study Completion

May 29, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

ES(1)