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NCT Number: NCT04570319

Clinical Trial to Evaluate the Effect of a Probiotic in Acne

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica San Antonio de Murcia, Guadalupe, Murcia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic Bths-08

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  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

    • 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)

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

Secondary outcomes

  1. 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.

  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; 1-19 = Mild; 20-30 = Moderate; 31-38 = Severe; > 38 = Very severe

    Patients who have a reduction in the score of at least 30% are considered as responders to treatment.

  3. Use of antibiotic acne treatment

    Time frame: 12-week

    Days of antibiotic use for the acne treatment, registered by the patient.

  4. 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

  5. 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.

  6. 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.

  7. Treatment safety assessed by number of adverse events

    Time frame: 12-week

    Number of adverse events that occur during the treatment period.

Sponsors and collaborators

Lead sponsor

Bionou Research, S.L.

Network

Registry information

Official study title

A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2020
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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