Acne VulgarisNCT04216160
Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo.
A study testing ACN cream (YUN) in people with Acne Vulgaris, run by YUN NV at 1 site in Brazil.
Trial summary
In this study the topical use of cream with live probiotic bacteria was evaluated for its efficacy in reducing acne symptoms and its effect on the skin microbiota on patients with acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ACN cream (YUN)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 5 May 2019to 11 Feb 2020
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy skin in the test areas;
- Subjects willing and capable to follow the study rules and a fixed schedule;
- Ability of giving consent for participation in the study;
- Subjects with good health in general and good mental condition;
- Subjects who present at least 10 inflammatory lesions;
- Oily skin on the face (minimum sebumetry value 100µg/cm² on frontal area (mean: 3 measurements)).
Who cannot join
- Pregnancy or breastfeeding;
- Subjects who present severe acne;
- Subjects who present more than two nodular lesions;
- Subjects who changed their oral contraception method up to three months before the study beginning;
- Subjects who did acne hormonal treatment less than 6 months before the study;
- Subjects who did oral isotretinoïne treatment less than 1 month before the study;
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- Subjects who did topical acne treatment less than 90 months before the study;
- Subjects who did aesthetic treatment less than 6 months before the study (like laser and peeling);
- Subjects who did treatment with antibiotics within the last 4 months;
- Simultaneous participation in different studies from external research institutes on the same test sites;
- Inadequate language proficiency (spoken and written);
- Participate in the study under the influence of alcohol and/or drugs as well as addiction;
- Severe psychological disease or intellectual disability of understanding the study;
- Severe disease (heart/circulatory/liver, kidney and lungs disease, severe diabetes mellitus) or chronic infections (hepatitis, HIV);
- Immune insufficiency;
- Current use of the following topical or systemic medications: corticosteroids, immunosuppressive and anti-histaminic drugs;
- Skin diseases: vitiligo, psoriasis, atopic dermatitis;
- Confirmed allergies to cosmetic components or previous responses of intolerance after the application of cosmetic products of the same category of the investigational products;
- Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, São Paulo, 13084-791
About this study
Official title: Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo, Under Normal Use Conditions.
In this study the topical use of cream with live probiotic bacteria was evaluated for its efficacy in reducing acne symptoms and its effect on the skin microbiota on patients with acne vulgaris. Patients with mild to moderate acne used the probiotic cream for 8 weeks and clinical evaluation and microbiological sampling was done at start, 2, 4, 8 and 12 weeks (after 4 weeks without use of the product). Next-Generation Sequencing is used to analyze the skin microbiota of the patients.
Read the detailed description
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in acne. Acne vulgaris is known as a multifactorial condition, both hormonal triggers and environmental factors play a role. However, it is also known that Cutibacterium acnes and Staphylococcus spp. play an important role in the inflammation of the sebaceous gland follicles. Therefore, probiotic strains with antipathogenic activity against these bacteria and suitable for application to the skin are potentially able to restore the balance of the skin microbiota and reduce acne symptoms. The main objective of this study was to verify the skin acceptance and efficacy of the cream with live probiotic bacteria for acne treatment in comparison with a placebo. More specifically to evaluate the effect of the 'live' Lactobacillus species as 'active ingredient' in relation to acne symptoms and skin microbiome modulation.
- Conditions
- Acne Vulgaris
- Being tested
- ACN cream (YUN), Placebo cream (YUN)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACN cream (YUN)Other
Also called Topical cream with live probiotic bacteria
Application of the facial cream ACN (YUN) twice a day, for 8 weeks +/- 2 days. Assessment before product use (T0), after 2, 4 and 8 weeks +/- 2 days of product use (T2w, T4w and T8w, respectively) and after 4 weeks +/- 2 days without product use (T12w).
Placebo cream (YUN)Other
Application of the facial placebo cream twice a day, for 8 weeks +/- 2 days. Assessment before product use (T0), after 2, 4 and 8 weeks +/- 2 days of product use (T2w, T4w and T8w, respectively) and after 4 weeks +/- 2 days without product use (T12w).
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Patients with mild to moderate acne using ACN Cream Receives: Other: ACN cream (YUN) |
| Placebo | Experimental | Patients with mild to moderate acne using the placebo cream Receives: Other: Placebo cream (YUN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of inflammatory lesions compared to placebo.
The subjects were assessed by a trained technician in order to perform the acne lesions counting.
Measured: baseline, 2, 4 and 8 weeks of product use and 4 weeks without product use (Total 12 weeks).
Change of inflammatory lesions compared to baseline.
The subjects were assessed by a trained technician in order to perform the acne lesions counting.
Measured: baseline, 2, 4 and 8 weeks of product use and 4 weeks without product use (Total 12 weeks).
Overall tolerance of the treatment
Dermatological Assessment of Tolerance (DAT). On all visits, the dermatologist performed an assessment of the study subjects' faces according to a 5-point scale. The physician recorded in the subject's case report form possible discomforts sensation informed.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start5 May 2019
- Primary completion28 Nov 2019
- Study completion11 Feb 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- YUN NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergisa Pesquisa Dermato-Cosmetica LTDA
- Responsible party
- Sponsor
- Investigators
- Mariane Mosca, Principal investigator, Allergisa Pesquisa Dermato-Cosmética Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216160
- Sponsor's protocol ID
- 074785-01/02-04-19-PRV03
- Status last verified
- May 2021
- First submitted
- 26 Dec 2019
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo, Under Normal Use Conditions.
- ClinicalTrials.gov ID
- NCT04216160
- Acronym / sponsor ID
- 074785-01/02-04-19-PRV03
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- YUN NVIndustry (pharma, biotech, devices)
- Collaborators
- Allergisa Pesquisa Dermato-Cosmetica LTDA
- Study start
- 5 May 2019 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 2 Jan 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.
In this study the topical use of cream with live probiotic bacteria was evaluated for its efficacy in reducing acne symptoms and its effect on the skin microbiota on patients with acne vulgaris. Patients with mild to moderate acne used the probiotic cream for 8 weeks and clinical evaluation and microbiological sampling was done at start, 2, 4, 8 and 12 weeks (after 4 weeks without use of the product). Next-Generation Sequencing is used to analyze the skin microbiota of the patients.
Detailed description
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects have been extensively studied in the gastrointestinal niche but it becomes more and more clear that other niches are also interesting for the potential of probiotics. Recent breakthroughs in 'next generation sequencing' (NGS) technologies are making it now possible to map the microbiota after DNA extraction, which is very interesting for bacteria that are not or difficult to cultivate. The research into the microbiota of the skin with such new NGS technologies shows that there is also an equilibrium in the skin composition of the microbiota and that there is a disturbance of the skin microbiota in acne. Acne vulgaris is known as a multifactorial condition, both hormonal triggers and environmental factors play a role. However, it is also known that Cutibacterium acnes and Staphylococcus spp. play an important role in the inflammation of the sebaceous gland follicles. Therefore, probiotic strains with antipathogenic activity against these bacteria and suitable for application to the skin are potentially able to restore the balance of the skin microbiota and reduce acne symptoms. The main objective of this study was to verify the skin acceptance and efficacy of the cream with live probiotic bacteria for acne treatment in comparison with a placebo. More specifically to evaluate the effect of the 'live' Lactobacillus species as 'active ingredient' in relation to acne symptoms and skin microbiome modulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Other: ACN cream (YUN)Patients with mild to moderate acne using ACN Cream |
| Placebo | Experimental | Other: Placebo cream (YUN)Patients with mild to moderate acne using the placebo cream |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy skin in the test areas;
- Subjects willing and capable to follow the study rules and a fixed schedule;
- Ability of giving consent for participation in the study;
- Subjects with good health in general and good mental condition;
- Subjects who present at least 10 inflammatory lesions;
Key exclusion criteria (19 listed)
- Pregnancy or breastfeeding;
- Subjects who present severe acne;
- Subjects who present more than two nodular lesions;
- Subjects who changed their oral contraception method up to three months before the study beginning;
- Subjects who did acne hormonal treatment less than 6 months before the study;
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 |
|---|---|---|
| ACN cream (YUN)Also: Topical cream with live probiotic bacteriaApplication of the facial cream ACN (YUN) twice a day, for 8 weeks +/- 2 days. Assessment before product use (T0), after 2, 4 and 8 weeks +/- 2 days of product use (T2w, T4w and T8w, respectively) and after 4 weeks +/- 2 days without product use (T12w). | Other | Verum |
| Placebo cream (YUN)Application of the facial placebo cream twice a day, for 8 weeks +/- 2 days. Assessment before product use (T0), after 2, 4 and 8 weeks +/- 2 days of product use (T2w, T4w and T8w, respectively) and after 4 weeks +/- 2 days without product use (T12w). | Other | Placebo |
Primary outcome
Change of inflammatory lesions compared to placebo.
Time frame: baseline, 2, 4 and 8 weeks of product use and 4 weeks without product use (Total 12 weeks).
The subjects were assessed by a trained technician in order to perform the acne lesions counting.
Change of inflammatory lesions compared to baseline.
Time frame: baseline, 2, 4 and 8 weeks of product use and 4 weeks without product use (Total 12 weeks).
The subjects were assessed by a trained technician in order to perform the acne lesions counting.
Overall tolerance of the treatment
Time frame: Baseline to week 12
Dermatological Assessment of Tolerance (DAT). On all visits, the dermatologist performed an assessment of the study subjects' faces according to a 5-point scale. The physician recorded in the subject's case report form possible discomforts sensation informed.
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 17 May 2021.
- Individual participant dataSharing planned: No
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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.
Mariane Mosca principal investigator
Allergisa Pesquisa Dermato-Cosmética Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACN cream (YUN) in people with Acne Vulgaris, run by YUN NV at 1 site in Brazil.
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 6 inclusion and 19 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 17 May 2021. 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 Brazil. 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. 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 of inflammatory lesions compared to placebo. (time frame: baseline, 2, 4 and 8 weeks of product use and 4 weeks without product use (Total 12 weeks).). The study lists 3 primary outcomes in all. 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 17 May 2021.