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.
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.
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?
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.