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

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ClinicalTrials.gov Identifier: NCT03878238
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bionou Research, S.L.

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.

Condition or disease Intervention/treatment Phase
Acne Acne Vulgaris Dietary Supplement: Probiotic Bths-003 Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind and Placebo-controlled Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne Vulgaris
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
Placebo with maltodextrin base.

Experimental: Probiotic Dietary Supplement: Probiotic Bths-003
Probiotic with maltodextrin as a carrier.




Primary Outcome Measures :
  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 Outcome Measures :
  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

    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. 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.



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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.
  • 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.

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): NCT03878238


Contacts
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Contact: Laura Navarro Moratalla +34 965 67 66 02 administracion@bionou.es

Locations
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Spain
Hospital Vithas Nisa 9 de Octubre Recruiting
Valencia, Spain, 46015
Contact: Laura Navarro Moratalla    +34 965 67 66 02    administracion@bionou.es   
Sponsors and Collaborators
Bionou Research, S.L.

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Responsible Party: Bionou Research, S.L.
ClinicalTrials.gov Identifier: NCT03878238     History of Changes
Other Study ID Numbers: ACNE_PROB
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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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

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases