AcneNCT04570319
Clinical Trial to Evaluate the Effect of a Probiotic in Acne
A study testing Probiotic Bths-08 in people with Acne and Acne Vulgaris, run by Bionou Research, S.L. at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Acne, Acne Vulgaris
- What is being tested?
- Probiotic Bths-08
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 4 sitesSpain
- Study dates
- 29 Apr 2020to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Centro Dermatológico Estético de Alicante
Alicante, 03014
Hospital Universitari Sagrat Cor
Barcelona
Universidad Católica San Antonio de Murcia
Guadalupe, Murcia, 30107
Clínica Eguren Dermatología y Estética
Madrid, 28006
About this study
Official title: A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With 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.
Read the 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.
- Conditions
- Acne, Acne Vulgaris
- Being tested
- Probiotic Bths-08, Placebo
- Keywords
- Probiotic, Acne, Microbiome, Microbiota, Symbiotic
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Bths-08Dietary supplement
A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks
PlaceboDietary supplement
A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Bths-08 | Experimental | a capsule containing the probiotic blend (nutritional complement) Receives: Dietary Supplement: Probiotic Bths-08 |
| Placebo | Placebo comparator | a capsule containing placebo comparator Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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.
Measured: 0 and 12-week
Secondary outcomes (7)
Change from baseline in the number of acne lesions at week 12
Number of non-inflammatory, inflammatory and total acne lesions.
Measured: 0 and 12-week
Change from baseline in the GAGS (Global Acne Grading System) index at week 12
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.
Measured: 0 and 12-week
Use of antibiotic acne treatment
Days of antibiotic use for the acne treatment, registered by the patient.
Measured: 12-week
Change from the baseline in the patient subjective evaluation index at week 12
Min score (Best) = 6 Max score (Worst) = 30
Measured: 0 and 12-week
Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome
Skin sample and genomic and microbiological analysis.
Measured: 0 and 12-week
Adherence to treatment
Compliance rate (in percentage) calculated as the number of leftover capsules divided by the total number of days between visits.
Measured: 12-week
Treatment safety assessed by number of adverse events
Number of adverse events that occur during the treatment period.
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start29 Apr 2020
- Primary completion21 Jul 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionou Research, S.L.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Vicente Navarro-Lopez, PhD; MD, Principal investigator, Universidad Católica San Antonio de Murcia (UCAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570319
- Sponsor's protocol ID
- ACNE.PROBI
- Status last verified
- Feb 2023
- First submitted
- 16 Apr 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne
- ClinicalTrials.gov ID
- NCT04570319
- Acronym / sponsor ID
- ACNE.PROBI
- Conditions
- Acne, Acne Vulgaris
- Keywords
- Probiotic, Acne, Microbiome, Microbiota, Symbiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Bionou Research, S.L.Research network
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Bths-08 | Experimental | Dietary Supplement: Probiotic Bths-08a capsule containing the probiotic blend (nutritional complement) |
| Placebo | Placebo comparator | Dietary Supplement: Placeboa capsule containing placebo comparator |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Bths-08A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks | Dietary supplement | Probiotic Bths-08 |
| PlaceboA capsule containing the placebo (dietary supplement), administered one daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
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) Patients who improve in at least one category of the scale are considered as responders to treatment.
7 secondary outcomes
Change from baseline in the number of acne lesions at week 12
Time frame: 0 and 12-week
Change from baseline in the GAGS (Global Acne Grading System) index at week 12
Time frame: 0 and 12-week
Use of antibiotic acne treatment
Time frame: 12-week
Change from the baseline in the patient subjective evaluation index at week 12
Time frame: 0 and 12-week
Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome
Time frame: 0 and 12-week
Adherence to treatment
Time frame: 12-week
Treatment safety assessed by number of adverse events
Time frame: 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente Navarro-Lopez, PhD; MD principal investigator
Universidad Católica San Antonio de Murcia (UCAM)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Bths-08 in people with Acne and Acne Vulgaris, run by Bionou Research, S.L. at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks (time frame: 0 and 12-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.