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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acne Vulgaris
- Sponsor
- BMG Pharma
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Serious Adverse Device event incidence
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Serious Adverse Device event incidence
Time Frame: 8 weeks
To evaluate the safety of the device trough Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Change in total number of lesions
Time Frame: 8 weeks
To evaluate the overall performance of the medical device Ialuxid Gel in the treatment of acne vulgaris, and folliculitis in terms of change in the total number of lesions, according to lesions count performed by Investigator (sum of lesions present on the body area mainly interested by each disease, to be specified in CRF).
Serious Adverse event incidence
Time Frame: 8 weeks
To evaluate the safety of the device trough Serious Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Adverse Device event incidence
Time Frame: 8 weeks
To evaluate the safety of the device trough Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Anticipated Serious Adverse Device event incidence
Time Frame: 8 weeks
To evaluate the safety of the device trough Anticipated Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Adverse event incidence
Time Frame: 8 weeks
To evaluate the safety of the device trough Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Unexpected Serious Adverse Device event incidence
Time Frame: 8 weeks
To evaluate the safety of the device trough Unexpected Serious Adverse Device Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Secondary Outcomes
- Treatment satisfaction questionnaire(8 weeks)
- Investigator Global Assessment of Performance (IGAP)(8 weeks)
- Global Acne Grading System (GAGS)(8 weeks)
- Investigator Global Assessment of Performance (IGAS)(8 weeks)
- Dermatology Life Quality Index (DLQI)(8 weeks)
- Change in total number of lesions(4 weeks)
- Total Severity Score (TSS)(8 weeks)
- Patient Global Assessment of Performance (PGAS)(8 weeks)