Acne VulgarisPhase 2YSHNCT05755256
The Impact of Probiotics on Skin Hydration in Youth with Mild Acne
A Phase 2 study testing Probiotic in people with Acne Vulgaris and Hydration Acne, run by Lallemand Health Solutions at 1 site in France.
Trial summary
The goal of this clinical trials is to test the impact of probiotics on skin hydration in adolescents and young adults with mild acne. The hypothesis of this study is that the probiotic formulation is superior to placebo in improving the skin hydration in adolescents and young adults with minimal acne after 12 weeks… Read more about this study
- Who is it for?
- Ages 15 months to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Hydration Acne
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2023to 18 Sep 2024
- Phase
- Phase 2
- 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 15 months to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 15 and 26 years (limits included),
- Suffering from mild acne vulgaris for at least 1 year (GEA score 1 or 2),
- For women (adolescents and adults) who have started their sexual life: be menstruated and with the same reliable contraception method since at least six months before the beginning of the study and agreeing to keep it during the entire duration of the study. Following contraception methods are allowed: hormonal contraception, intra uterine device, surgical intervention, condoms with spermicides. Contraceptive implants (e.g. Nexplanon®) are not allowed. For women who have not started their sexual life yet, who do not intend to start their sexual life, who do not use a contraception: be menstruated and keep the habits unchanged;
- For women (adolescents and adults): negative urine pregnancy test result;
- Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination;
- Agree to maintain the same skin care regimen throughout the study;
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- Able and willing to participate in the study by complying with the protocol procedures, as evidenced by their dated and signed informed consent form. For adolescents (15-17 years): informed consent form signed by the guardians/parents and the individual willing to participate;
- Affiliated with a social security scheme. For adolescents: affiliated with the social security scheme of the guardians/parents;
- Agreeing to be registered on the national file of volunteers in biomedical research file.
- After 1 month following to the non-inclusion of the participant for failure to comply with one or more of the inclusion criteria listed above, a re-screening could be performed.
Who cannot join
- GEA score <1 or > 2 (corresponding to the absence of acne or a moderate, severe or very severe acne vulgaris),
- Any disease that affects the secretion of sex hormones,
- Any other dermatological disease (psoriasis, atopic dermatitis, allergy, eczema, etc.);
- Suffering from a metabolic disorder (diabetes, uncontrolled thyroidal condition, uncontrolled arterial hypertension, etc.) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease, etc.) or from a disease found to be inconsistent with the conduct of the study by the investigator;
- Immunodeficiency (immunodeficient and immunocompromised participants, e.g. cancer, HIV, lymphoma, participants on long-term corticosteroid treatment, chemotherapy, and allograft participants);
- Positive COVID-test results within the last 2 weeks and/or currently showing symptoms of COVID-19;
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- Use of any systemic antibiotic or oral zinc treatment within 4 weeks prior to randomization, or isotretinoin within 3 months prior to randomization.
- Regular consumption of probiotics, fiber supplements, fermented milk, and/or yogurt containing probiotics within 2 weeks prior to randomization and agreeing not to consume this type of product during the whole study;
- Use of hormone replacement therapy (including oral contraceptives) for less than 6 months;
- Under treatment or dietary supplement which could significantly affect skin microbiota according to the investigator or stopped in a too short period before V1;
- Use of topically applied products (including topical acne drug) that could modulate potential skin improvement within 4 weeks prior to randomization. This includes products with a pH ≥ 8 such as hormone treatments, retinoid and other skin cleansing products, Micellar waters pH ≤ 5 can be used without rubbing the skin too hard with a cotton wool pad in order not to induce a Köbner phenomenon (appearance of new acne lesions on healthy but traumatised skin);
- UVA or UVB exposure in the last 4 weeks or expected exposure during the study (short daily sun exposure is acceptable). The use of a UVA and UVB protection sunscreen factor 50 is mandatory during the study to protect against UVs;
- With a known or suspected food allergy or intolerance or hypersensitivity to ingredient of the study products (yeast);
- Pregnant or lactating women or intending to become pregnant within 3 months ahead;
- With significant change in dietary or physical activity habits in the 3 months before randomization and not agreeing to keep them unchanged throughout the study (hyper or hypocaloric diet, planned start or stop of sports activity in the next 3 months);
- With a personal history of anorexia nervosa, bulimia, or significant eating disorders within 3 years prior to randomization;
- Consuming more than 2 standard drinks daily of alcoholic beverages or not willing to maintain their drinking habits unchanged throughout the study;
- Participating in another clinical trial or in the exclusion period of a previous clinical trial, or participating in cosmetic tests with or without patch tests or consumer tests with food supplements containing probiotics;
- Smoking more than 5 cigarettes per day;
- For adults (age ≥ 18 years): Under legal protection (guardianship, wardship) or deprived of his/her rights following an administrative or judicial decision;
- Presenting psychological or linguistic incapability to sign the informed consent;
- Impossible to contact in case of emergency;
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros.
- After 1 month following to the non-inclusion of the participant for failure to comply with one or more of the exclusion criteria listed above, a re-screening could be performed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial to Assess the Impact of Probiotics on Skin Hydration in Adolescents and Young Adults with Mild Acne Vulgaris.
The goal of this clinical trials is to test the impact of probiotics on skin hydration in adolescents and young adults with mild acne. The hypothesis of this study is that the probiotic formulation is superior to placebo in improving the skin hydration in adolescents and young adults with minimal acne after 12 weeks of consumption.
Read the detailed description
This pilot study is a monocentric, randomized, double-blind, placebo-controlled, parallel-arm study. The product allocation will be performed using a dynamic randomization algorithm designed to minimize imbalance between the 2 arms, within the strata defined by 3 factors: age, Global Acne Evaluation (GEA) score and sex.
60 participants (adolescents and adults) with mild acne vulgaris will be recruited for this study, according to the following inclusion and exclusion criteria.
There will be a total of 3 study visits: V1 (screening and randomization), V2 (mid-study follow-up), and V3 (end-of-study). The study will last a total of 12 weeks.
- Conditions
- Acne Vulgaris, Hydration Acne
- Being tested
- Probiotic, Placebo
- Keywords
- probiotics, acne, adolescents, young adults, skin hydration
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
After randomization, participants will consume the probiotic for 12 weeks.
PlaceboDietary supplement
After randomization, participants will consume the placebo for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | The product contains the probiotic strain and no other ingredients. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | The control product is a placebo with the same characteristics of appearance and packaging as the tested product. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal hydration after 12 weeks
The primary endpoint of the study is to compare the absolute change of the hydration level of the facial cornea between baseline (visit V1) and visit V3, assessed with Corneometer® CM825 on the forehead expressed in arbitrary units (a.u.) ranging from 0 to 120 (<30: very dry skin; 30-40: dry skin; >40: normal hydrated skin).
Measured: 12 weeks
Secondary outcomes (8)
Corneal hydration of the forehead after 6 weeks
The absolute change of the hydration of the facial cornea measured on the forehead with Corneometer® CM825 (expressed in a.u.) between V1 and V2, ranging from 0 to 120 (<30: very dry skin; 30-40: dry skin; >40: normal hydrated skin)).
Measured: 6 weeks
Transepidermal water loss of forehead skin
The absolute change of the transepidermal water loss (TEWL) measured on the forehead with Tewameter® TM300expressed in g/h/m² (0-10: very healthy; 10-15: healthy; 15-25: normal; 25-30: stretched skin; >30: critical), between V1 and each visit (V2, V3).
Measured: 12 weeks
Symptoms of acne on face
The absolute change of acne vulgaris symptoms (face and back) assessed with the Échelle de Cotation des Lésions d'Acné (acne grading scale; ECLA) scale between V1 and each visit (V2, V3), expressed in a.u, ranging from 0 to 5 on the face (0: no lesions; 1: <5; 2: 5-9; 3: 10-19; 4: 20-40; 5: > 40 lesions), and ranging from 0 to 3 on the back (0: absent; 1: few; 2: moderate; 3: important).
Measured: 12 weeks
Sebum levels on face
The absolute change of sebum level (expressed in μg/cm²) measured with Sebumeter® SM815 between V1 and V3, ranging from 0 to 350, on the forehead (<100: dry skin; 100-220: normal skin; >220: oily skin).
Measured: 12 weeks
Disability caused by acne
The absolute change of disability caused by acne assessed with the Cardiff Acne Disability Index (CADI) score (expressed in a.u., range 0-15) between V1 and each visit (V2, V3).
Measured: 12 weeks
Impact on quality of life
The absolute change of overall Quality of Life, general health and four quality of life domains (Physical, Psychological, Social Relationships and Environment) assessed with six sub-scores of the World Health Organization Quality of life questionnaire - Brief version (WHOQoL-BREF) (expressed in a.u., item scores range 1-5, transformed scores range 0-100) between V1 and each visit (V2, V3).
Measured: 12 weeks
Self-assessment of acne level on face and back
The absolute change of self-assessment acne level assessed with a visual analogue scale (VAS, range 0-10) between V1 and each visit (V2, V3).
Measured: 12 weeks
Self-assessment of treatment satisfaction
The global study product satisfaction assessed with a visual analogue scale VAS (range 0-10) at V2 and V3.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start4 Sep 2023
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This pilot study is a monocentric, randomized, double-blind, placebo-controlled, parallel-arm study. The product allocation will be performed using a dynamic randomization algorithm designed to minimize imbalance between the 2 arms, within the strata defined by 3 factors: age, Global Acne Evaluation (GEA) score and sex.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
- Investigators
- Isabelle Metreau, M.D, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755256
- Sponsor's protocol ID
- L-023
- Acronym
- YSH
- Status last verified
- Jul 2024
- First submitted
- 9 Feb 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial to Assess the Impact of Probiotics on Skin Hydration in Adolescents and Young Adults with Mild Acne Vulgaris.
- ClinicalTrials.gov ID
- NCT05755256
- Acronym / sponsor ID
- YSH / L-023
- Conditions
- Acne Vulgaris, Hydration Acne
- Keywords
- probiotics, acne, adolescents, young adults, skin hydration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 6 Mar 2023 (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.
The goal of this clinical trials is to test the impact of probiotics on skin hydration in adolescents and young adults with mild acne. The hypothesis of this study is that the probiotic formulation is superior to placebo in improving the skin hydration in adolescents and young adults with minimal acne after 12 weeks of consumption.
Detailed description
This pilot study is a monocentric, randomized, double-blind, placebo-controlled, parallel-arm study. The product allocation will be performed using a dynamic randomization algorithm designed to minimize imbalance between the 2 arms, within the strata defined by 3 factors: age, Global Acne Evaluation (GEA) score and sex.
60 participants (adolescents and adults) with mild acne vulgaris will be recruited for this study, according to the following inclusion and exclusion criteria.
There will be a total of 3 study visits: V1 (screening and randomization), V2 (mid-study follow-up), and V3 (end-of-study). The study will last a total of 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This pilot study is a monocentric, randomized, double-blind, placebo-controlled, parallel-arm study. The product allocation will be performed using a dynamic randomization algorithm designed to minimize imbalance between the 2 arms, within the strata defined by 3 factors: age, Global Acne Evaluation (GEA) score and sex.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticThe product contains the probiotic strain and no other ingredients. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe control product is a placebo with the same characteristics of appearance and packaging as the tested product. |
Who may qualify
- Ages
- 15 months to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age between 15 and 26 years (limits included),
- Suffering from mild acne vulgaris for at least 1 year (GEA score 1 or 2),
- For women (adolescents and adults) who have started their sexual life: be menstruated and with the same reliable contraception method since at least six months before the beginning of the study and agreeing to keep it during the entire duration of the study. Following contraception methods are allowed: hormonal contraception, intra uterine device, surgical intervention, condoms with spermicides. Contraceptive implants (e.g. Nexplanon®) are not allowed. For women who have not started their sexual life yet, who do not intend to start their sexual life, who do not use a contraception: be menstruated and keep the habits unchanged;
- For women (adolescents and adults): negative urine pregnancy test result;
- Good general and mental health within the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination;
Key exclusion criteria (24 listed)
- GEA score <1 or > 2 (corresponding to the absence of acne or a moderate, severe or very severe acne vulgaris),
- Any disease that affects the secretion of sex hormones,
- Any other dermatological disease (psoriasis, atopic dermatitis, allergy, eczema, etc.);
- Suffering from a metabolic disorder (diabetes, uncontrolled thyroidal condition, uncontrolled arterial hypertension, etc.) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease, etc.) or from a disease found to be inconsistent with the conduct of the study by the investigator;
- Immunodeficiency (immunodeficient and immunocompromised participants, e.g. cancer, HIV, lymphoma, participants on long-term corticosteroid treatment, chemotherapy, and allograft participants);
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 |
|---|---|---|
| ProbioticAfter randomization, participants will consume the probiotic for 12 weeks. | Dietary supplement | Probiotic |
| PlaceboAfter randomization, participants will consume the placebo for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Corneal hydration after 12 weeks
Time frame: 12 weeks
The primary endpoint of the study is to compare the absolute change of the hydration level of the facial cornea between baseline (visit V1) and visit V3, assessed with Corneometer® CM825 on the forehead expressed in arbitrary units (a.u.) ranging from 0 to 120 (<30: very dry skin; 30-40: dry skin; >40: normal hydrated skin).
8 secondary outcomes
Corneal hydration of the forehead after 6 weeks
Time frame: 6 weeks
Transepidermal water loss of forehead skin
Time frame: 12 weeks
Symptoms of acne on face
Time frame: 12 weeks
Sebum levels on face
Time frame: 12 weeks
Disability caused by acne
Time frame: 12 weeks
Impact on quality of life
Time frame: 12 weeks
Self-assessment of acne level on face and back
Time frame: 12 weeks
Self-assessment of treatment satisfaction
Time frame: 12 weeks
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 20 Sep 2024.
- Individual participant dataSharing planned: No. After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
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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.
Isabelle Metreau, M.D principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Acne Vulgaris and Hydration Acne, run by Lallemand Health Solutions at 1 site in France.
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 10 inclusion and 24 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 20 Sep 2024. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Corneal hydration after 12 weeks (time frame: 12 weeks). 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 20 Sep 2024.