AcneNCT03878238
A Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne
A study testing Probiotic Bths-003 in people with Acne and Acne Vulgaris, run by Bionou Research, S.L. at 1 site in Spain.
Trial 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. 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-003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jul 2018to 29 May 2019
- 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.
- Moderate acne according to the AGSS (Acne Global Severity Scale) and / or GAGS (Global Acne Grading System) scales.
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
1 site in 1 country.
About this study
Official title: Randomized, Double Blind and Placebo-controlled Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne Vulgaris
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.
- Conditions
- Acne, Acne Vulgaris
- Being tested
- Probiotic Bths-003, Placebo
- Keywords
- Probiotic
- 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-003Dietary supplement
Probiotic with maltodextrin as a carrier.
PlaceboOther
Placebo with maltodextrin base.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Probiotic | Experimental | Not described Receives: Dietary Supplement: Probiotic Bths-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in GAGS (Global Acne Grading System) index score at 12 weeks
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
Measured: 12-week
Secondary outcomes (5)
AGSS (Acne Global Severity Scale) index score
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)
Measured: 0, 6 and 12-week
Number of acne lesions
Number of non-inflammatory, inflammatory and total acne lesions.
Measured: 0, 6 and 12-week
Patient subjective evaluation
Min score (Best) = 6 Max score (Worst) = 30
Measured: 0, 6 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 posted18 Mar 2019
- Study start11 Jul 2018
- Primary completion15 Apr 2019
- Study completion29 May 2019
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionou Research, S.L.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878238
- Sponsor's protocol ID
- ACNE_PROB
- Status last verified
- Jul 2019
- First submitted
- 14 Mar 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind and Placebo-controlled Pilot Study to Evaluate the Effect of a Probiotic Mixture in Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03878238
- Acronym / sponsor ID
- ACNE_PROB
- Conditions
- Acne, Acne Vulgaris
- Keywords
- Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bionou Research, S.L.Research network
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 18 Mar 2019 (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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Probiotic | Experimental | Dietary Supplement: Probiotic Bths-003 |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 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.
- Moderate acne according to the AGSS (Acne Global Severity Scale) and / or GAGS (Global Acne Grading System) scales.
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-003Probiotic with maltodextrin as a carrier. | Dietary supplement | Probiotic |
| PlaceboPlacebo with maltodextrin base. | Other | Placebo |
Primary outcome
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
5 secondary outcomes
AGSS (Acne Global Severity Scale) index score
Time frame: 0, 6 and 12-week
Number of acne lesions
Time frame: 0, 6 and 12-week
Patient subjective evaluation
Time frame: 0, 6 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 10 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Bths-003 in people with Acne and Acne Vulgaris, run by Bionou Research, S.L. at 1 site 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 3 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 GAGS (Global Acne Grading System) index score at 12 weeks (time frame: 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 10 Jul 2019.