Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis (NCT05345093) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Safety and Performance of Ialuxid Gel in Treatment of Acne Vulgaris, and Folliculitis
Romania66 participantsStarted 2022-11-11
Plain-language 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?
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Men or women aged ≥ 18 and ≤ 45 years.
✓. Patients diagnosed with acne vulgaris, and folliculitis.
✓. Patients willing to provide signed informed consent to clinical investigation participation.
✓. Patients who agree to discontinue all dermatological treatment and procedures during the study.
✓. Patients able to communicate adequately with the Investigator and to comply with the requirements for the study.
Exclusion criteria
✕. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\* during the study.
✕. Patients with history of allergy or hypersensitivity to Hyaluronic Acid or to any other ingredients of Ialuxid® Gel or hypersensitivity skin reaction to Ialuxid® Gel based on skin test results.
✕. History of anaphylaxis or severe complicated allergy symptoms.
✕. Patients with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma.
✕. Patients who have used oral drugs for acne vulgaris, and folliculitis in the previous month.
✕. Patients who have used topical therapies for acne vulgaris, and folliculitis in the previous month.
. Use of concomitant treatments or procedures aimed to improve skin condition over the last six months before the enrolment, such as chemical peeling, dermabrasion, laser resurfacing.
✕. Patients suffering from infectious diseases that would compromise participation, including herpes simplex virus infection, active hepatitis, or human immunodeficiency virus.