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

NCT04216160 | Completed

• 1 other identifier: 074785-01/02-04-19-PRV03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• Change of inflammatory lesions compared to placebo.

  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.

  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

  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

Study Arms (2)

Verum

EXPERIMENTAL

Patients with mild to moderate acne using ACN Cream

Other: ACN cream (YUN)

Placebo

EXPERIMENTAL

Patients with mild to moderate acne using the placebo cream

Other: Placebo cream (YUN)

Interventions

ACN cream (YUN) OTHER

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).

Also known as: Topical cream with live probiotic bacteria

Verum

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).

Placebo

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)).

You may not qualify if:

• 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;

Sponsors & Collaborators

• YUN NV: lead
• Allergisa Pesquisa Dermato-Cosmetica LTDA: collaborator

Study Sites (1)

Allergisa Pesquisa Dermato-Cosmética Ltda

Campinas, São Paulo, 13084-791, Brazil

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Mariane Mosca

  Allergisa Pesquisa Dermato-Cosmética Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: January 2, 2020
• Study Start: May 5, 2019
• Primary Completion: November 28, 2019
• Study Completion: February 11, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)