NCT05345093

Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis

Open, Non-comparative, Multicentre, Interventional Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Ialuxid® Gel (Hydrogen Peroxide and Hyaluronic Acid) in the Treatment of Acne Vulgaris and Folliculitis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: BMG Pharma · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The Research Question of the present study is the following: in a population of men and women affected by acne vulgaris, and folliculitis, will Ialuxid® Gel (hydrogen peroxide, hyaluronic acid and glycine) improve the course of the disease, resulting in a decrease of the total number of lesions, results observed after 4 and 8 weeks after the beginning of the treatment?

Detailed description

Ialuxid® Gel is a non-antibiotic treatment in gel indicated for use in a variety of skin conditions, and also in case of infection. Its principal ingredient is Ialuvance™ Complex, a proprietary association of hydrogen peroxide, hyaluronic acid, and glycine.

Conditions

• Acne Vulgaris
• Folliculitis

Interventions

Type	Name	Description
DEVICE	Ialuxid gel	Ialuxid® Gel is intended for topical external use. It is formulated with the appearance of white to pale yellow coloured consistent gel. Ialuxid® Gel will be used for 8 weeks, 2-3 times a day.

Timeline

• Start date: 2022-11-11
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2022-04-25
• Last updated: 2024-05-21

Locations

1 site across 1 country: Romania