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Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo.

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ACN cream (YUN)
Placebo cream (YUN)
Sponsored by
YUN NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Allergisa Pesquisa Dermato-Cosmética Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Verum

Placebo

Arm Description

Patients with mild to moderate acne using ACN Cream

Patients with mild to moderate acne using the placebo cream

Outcomes

Primary Outcome Measures

Change of inflammatory lesions compared to placebo.
The subjects were assessed by a trained technician in order to perform the acne lesions counting.
Change of inflammatory lesions compared to baseline.
The subjects were assessed by a trained technician in order to perform the acne lesions counting.
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.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2019
Last Updated
May 14, 2021
Sponsor
YUN NV
Collaborators
Allergisa Pesquisa Dermato-Cosmetica LTDA
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1. Study Identification

Unique Protocol Identification Number
NCT04216160
Brief Title
Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo.
Official Title
Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo, Under Normal Use Conditions.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2019 (Actual)
Primary Completion Date
November 28, 2019 (Actual)
Study Completion Date
February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
YUN NV
Collaborators
Allergisa Pesquisa Dermato-Cosmetica LTDA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Experimental
Arm Description
Patients with mild to moderate acne using ACN Cream
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Patients with mild to moderate acne using the placebo cream
Intervention Type
Other
Intervention Name(s)
ACN cream (YUN)
Other Intervention Name(s)
Topical cream with live probiotic bacteria
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo cream (YUN)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change of inflammatory lesions compared to placebo.
Description
The subjects were assessed by a trained technician in order to perform the acne lesions counting.
Time Frame
baseline, 2, 4 and 8 weeks of product use and 4 weeks without product use (Total 12 weeks).
Title
Change of inflammatory lesions compared to baseline.
Description
The subjects were assessed by a trained technician in order to perform the acne lesions counting.
Time Frame
baseline, 2, 4 and 8 weeks of product use and 4 weeks without product use (Total 12 weeks).
Title
Overall tolerance of the treatment
Description
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.
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariane Mosca
Organizational Affiliation
Allergisa Pesquisa Dermato-Cosmética Ltda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergisa Pesquisa Dermato-Cosmética Ltda
City
Campinas
State/Province
SP
ZIP/Postal Code
13084-791
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Skin Acceptance and Efficacy Assessment of a Topical Product in Acne Treatment When Compared to a Placebo.

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