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

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.

Inclusion criteria

• Men or women aged ≥ 18 and ≤ 45 years.
• Patients diagnosed with acne vulgaris, and folliculitis.

a. Only for patients with acne vulgaris: mild to moderate Global Acne Grading Scale score (≤ 30).

• 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.

*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).

• 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.
• Patients at risk in term of precautions, warnings and contra-indications referred in the package insert of Ialuxid® Gel.
• Patients with any facial aesthetic surgery (such as facial contouring surgery: rhinoplasty, chin, or cheek enhancement (through facial implant) or facial rejuvenation surgery: facelift, eyelid lift, neck lift or facial implants etc.) in the preceding 3 months before the enrolment.
• Patients who received filler injections of any typology in the face in the preceding 3 months.
• Patients who received botulinum toxin A injections in the face in the preceding 6 months.
• Need to have direct or indirect contact with quaternary ammonium salts during the study.
• Patients unlikely to cooperate.
• Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalization during the study.
• Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.