NCT06786442

Clinical Efficacy Evaluation of a Skincare Product for Acne Face, Upper Chest and Back Used by Multiphototype Population Under Dermatological Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Cosmetique Active International · Industry
• Sex: All
• Age: 16 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The present aims to confirm, under normal conditions of use, the IP's clinical efficacy in controlling acne on the face, upper chest, and back after 28 and 42 days of product use, as well as illustrate its efficacy through standardized pictures. In addition, it is expected to assess the sensations of discomfort reported by participants at cutaneous levels, taking into consideration the product use guidelines determined by the manufacturer, and the self-perceived efficacy by participants immediately after the first application, after 7, 28, 42 days using the IP

Detailed description

In accordance with ANVISA's definition on RDC 07 of 2015, personal hygiene products, cosmetics, and perfume are preparations composed of natural or synthetic substances, for external use on the various parts of the body such as skin, hair, nails, lips, external genital, teeth and mucous membranes of the oral cavity, with the exclusive or main purpose of cleaning and perfuming them, changing their appearance, correcting body odors, protecting and/or keeping them in good condition. It is of great importance that companies conduct clinical studies of their products so that consumers have maximum safety with the lowest risk of use. After confirming the evidence of safety of use by humans, the manufacturing company must submit the results obtained to ANVISA (whether the company intends to sell it in Brazil), as well as establishing label warnings and consumer service guidelines based on the information obtained. According to Helsinki Declaration and Brazilian legislation, any research involving human beings must comply with ethical premises. The purpose of them is to protect individuals' integrity, dignity, well-being, rights, and confidentiality. Therefore, studies involving personal care products, cosmetics and perfumes in safety investigation phase (i.e. investigational products) must follow the recommendations of Good Clinical Practices (GCP). STATISTICAL ANALYSIS PLAN For each study assessment area (face, upper chest, and back), four statistical analysis will be conducted: one global analysis and one analysis per phototype cluster (I-II, III-IV, and V-VI). A total of 12 statistical analysis will be performed. Parameters to be Analyzed: * Number of papules; * Number of pustules; * Number of nodules; * Number of blackheads; * Number of microcysts; * Number of excoriated lesions without inflammation; * Number of red acne residual marks; * Number of brown acne residual marks; * Number of inflammatory lesions (papules + pustules + nodules). Calculated parameter * Number of retentional lesions (blackhead + microcysts). Calculated parameter * Number of acne residual marks (red acne residual marks + brown acne residual marks). Calculated parameter * Number of other lesions (excoriated lesions without inflammation + residual marks). Calculated parameter ▪ Total number of lesions (inflammatory lesions + total lesions + other lesions). Calculated parameter

Conditions

• Acne

Interventions

Type	Name	Description
OTHER	EFFACLAR DUO+M CREAM	twice a day: morning and evening. Subjects should be able to self-apply the product on all assessment areas (face, upper chest, and back)

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-01-05
• Completion: 2024-01-26
• First posted: 2025-01-22
• Last updated: 2025-01-22

Locations

1 site across 1 country: Brazil