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Clinical Trial to Evaluate the Effect of a Probiotic in Acne

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ClinicalTrials.gov Identifier: NCT04570319
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Bionou Research, S.L.

Brief Summary:
A 12-week randomized, multicenter and double-blind, placebo-controlled pilot study to evaluate the effect of a probiotic in the clinical and subjective evolution of acne in adolescent and adult patients.

Condition or disease Intervention/treatment Phase
Acne Acne Vulgaris Dietary Supplement: Probiotic Bths-08 Dietary Supplement: Placebo Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Probiotic Bths-08
a capsule containing the probiotic blend (nutritional complement)
Dietary Supplement: Probiotic Bths-08
A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks

Placebo Comparator: Placebo
a capsule containing placebo comparator
Dietary Supplement: Placebo
A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks




Primary Outcome Measures :
  1. Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks [ Time Frame: 0 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)

  2. Change from baseline in the GAGS (Global Acne Grading System) index at week 12 [ Time Frame: 0 and 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


  3. Change from baseline in the number of acne lesions at week 12 [ Time Frame: 0 and 12-week ]
    Number of non-inflammatory, inflammatory and total acne lesions.


Secondary Outcome Measures :
  1. Change from the baseline in the patient subjective evaluation index at week 12 [ Time Frame: 0 and 12-week ]
    Min score (Best) = 6 Max score (Worst) = 30

  2. Use of antibiotic acne treatment [ Time Frame: 12-week ]
    Days of antibiotic use for the acne treatment, registered by the patient.

  3. Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome [ Time Frame: 0 and 12-week ]
    Skin sample and genomic and microbiological analysis.

  4. Change in the microbiome components on stool samples [ Time Frame: 0 and 12-week ]
    Stool sample and high-throughput sequencing data analysis.

  5. 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.

  6. Treatment safety assessed by number of adverse events [ Time Frame: 12-week ]
    Number of adverse events that occur during the treatment period.



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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570319


Contacts
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Contact: Laura Navarro-Moratalla 623022586 administracion@bionou.es

Locations
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Spain
Universidad Católica San Antonio de Murcia Recruiting
Guadalupe, Murcia, Spain, 30107
Contact: Vicente Navarro       vnavarro@ucam.edu   
Centro Dermatológico Estético de Alicante Recruiting
Alicante, Spain, 03014
Contact: Diego Vela         
Clínica Eguren Dermatología y Estética Recruiting
Madrid, Spain, 28006
Contact: Cristina Eguren         
Hospital Vithas Nisa 9 de Octubre-Valencia Withdrawn
Valencia, Spain, 46015
Sponsors and Collaborators
Bionou Research, S.L.
Investigators
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Principal Investigator: Vicente Navarro-Lopez, PhD; MD Universidad Católica San Antonio de Murcia (UCAM)
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Responsible Party: Bionou Research, S.L.
ClinicalTrials.gov Identifier: NCT04570319    
Other Study ID Numbers: ACNE.PROBI
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bionou Research, S.L.:
Probiotic
Acne
Microbiome
Microbiota
Symbiotic
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases