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Completed

NCT Number: NCT03878238

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

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.

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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

Hospital Vithas Nisa 9 de Octubre

Valencia, 46015, Spain

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.
  • 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.

Treatment and study plan

Probiotic Bths-003

Dietary Supplement

Probiotic with maltodextrin as a carrier.

Placebo

Other

Placebo with maltodextrin base.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    • = 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)

  2. Number of acne lesions

    Time frame: 0, 6 and 12-week

    Number of non-inflammatory, inflammatory and total acne lesions.

  3. Patient subjective evaluation

    Time frame: 0, 6 and 12-week

    Min score (Best) = 6 Max score (Worst) = 30

  4. 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.

  5. 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

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2019
Registry last updated
Jul 10, 2019

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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