A Phase 2 interventional study of Probiotic and Placebo in Acne Vulgaris and Hydration Acne, sponsored by Lallemand Health Solutions. Completed at 1 site in France. Open to participants aged 15 Months to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Lallemand Health Solutions · Phase 2, Interventional, and Supportive care
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.
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 58 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Lallemand Health Solutions is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The product contains the probiotic strain and no other ingredients.
Dietary Supplement: Probiotic
The control product is a placebo with the same characteristics of appearance and packaging as the tested product.
Dietary Supplement: Placebo
After randomization, participants will consume the probiotic for 12 weeks.
After randomization, participants will consume the placebo for 12 weeks.
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).
Time frame: 12 weeks
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)).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 12 weeks
Skin microbiota composition
The change in skin microbiota composition (by sequencing for V3-V4 regions of 16S rRNA genes) between V1 and V3. Comparisons will be made in terms of relative abundance at the Phylum, Family and Genus taxonomic ranks, alpha-diversity indices (observed richness, inverse Simpson and Shannon) and beta-diversity indices (Jaccard and Bray-Curtis).
Time frame: 12 weeks
Quantification of probiotic in stool samples
The change in the quantity of the probiotics (by qPCR) between V1 and V3 in stool samples.
Time frame: 12 weeks
Faecal microbiota composition
The change in fecal microbiota composition assessed via Shotgun metagenomic analysis at each visit V1, V2 and V3. Comparisons will be made in terms of relative abundance at the Phylum, Family, Genus and Species taxonomic ranks for bacterial and eukaryota compositions, alpha-diversity indices (observed richness, inverse Simpson and Shannon) and beta-diversity indices (Jaccard and Bray-Curtis).
Time frame: 12 weeks
Vital signs - heart rate
The absolute change in values between baseline (V1) and each visit (V2 and V3) for Heart Rate (HR, in bpm).
Time frame: 12 weeks
Vital signs - blood pressure
The absolute change in values between baseline (V1) and each visit (V2 and V3) for the Systolic Blood Pressure (SBP, in mmHg) and Diastolic Blood Pressure (DBP, in mmHg).
Time frame: 12 weeks
Frequency of adverse events
The frequency of adverse events (AEs): treatment emergent adverse events (TEAEs), treatment emergent serious adverse events (STEAEs), TEAEs leading to discontinuation of study product, treatment emergent adverse reactions (TEARs).
Time frame: 12 weeks
Gut tolerance of probiotic
The absolute change in values obtained with the Gastrointestinal Symptom Rating Scale (GSRS), which contains 15 items on a 7-point Likert scale (1 = "absence of troublesome symptoms", and 7 = "very troublesome symptoms"), between baseline (V1) and each visit (V2, V3).
Time frame: 12 weeks
Plan to share: 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).
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
Lallemand Health Solutions