NCT04570319

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

April 16, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

April 29, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

April 16, 2020

Last Update Submit

February 15, 2023

Conditions

AcneAcne Vulgaris

Keywords

ProbioticAcneMicrobiomeMicrobiotaSymbiotic

Outcome Measures

Primary Outcomes (1)

  • 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 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) Patients who improve in at least one category of the scale are considered as responders to treatment.

    0 and 12-week

Secondary Outcomes (7)

  • Change from baseline in the number of acne lesions at week 12

    0 and 12-week

  • Change from baseline in the GAGS (Global Acne Grading System) index at week 12

    0 and 12-week

  • Use of antibiotic acne treatment

    12-week

  • Change from the baseline in the patient subjective evaluation index at week 12

    0 and 12-week

  • Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome

    0 and 12-week

  • +2 more secondary outcomes

Study Arms (2)

Probiotic Bths-08

EXPERIMENTAL

a capsule containing the probiotic blend (nutritional complement)

Dietary Supplement: Probiotic Bths-08

Placebo

PLACEBO COMPARATOR

a capsule containing placebo comparator

Dietary Supplement: Placebo

Interventions

Probiotic Bths-08DIETARY_SUPPLEMENT

A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks

Probiotic Bths-08
PlaceboDIETARY_SUPPLEMENT

A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks

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.
  • AGSS (Acne Global Severity Scale) Score: 2 or higher
  • Patients who agree to follow the study's dietary recommendations.

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 (4)

Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Location

Centro Dermatológico Estético de Alicante

Alicante, 03014, Spain

Location

Hospital Universitari Sagrat Cor

Barcelona, Spain

Location

Clínica Eguren Dermatología y Estética

Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Vicente Navarro-Lopez, PhD; MD

    Universidad Católica San Antonio de Murcia (UCAM)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 16, 2020

First Posted

September 30, 2020

Study Start

April 29, 2020

Primary Completion

July 21, 2022

Study Completion

September 20, 2022

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations

ES(4)