- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216160
Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo.
May 14, 2021 updated by: YUN NV
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Campinas, SP, Brazil, 13084-791
- Allergisa Pesquisa Dermato-Cosmetica Ltda
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 33 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)).
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Verum
Patients with mild to moderate acne using ACN Cream
|
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).
Other Names:
|
Experimental: Placebo
Patients with mild to moderate acne using the placebo cream
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
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.
|
baseline, 2, 4 and 8 weeks of product use and 4 weeks without product use (Total 12 weeks).
|
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.
|
Baseline to week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mariane Mosca, Allergisa Pesquisa Dermato-Cosmetica Ltda
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2019
Primary Completion (Actual)
November 28, 2019
Study Completion (Actual)
February 11, 2020
Study Registration Dates
First Submitted
December 26, 2019
First Submitted That Met QC Criteria
December 31, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 14, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 074785-01/02-04-19-PRV03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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