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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
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.
SC Salvosan Ciobanca SRL
Zalău, Sălaj County, Romania
Change in total number of lesions
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).
Time frame: 8 weeks
Adverse event incidence
To evaluate the safety of the device trough Adverse Event incidence assessed by Investigators at all visits and reported according to the current legislation.
Time frame: 8 weeks
Serious Adverse event incidence
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.
Time frame: 8 weeks
Adverse Device event incidence
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.
Time frame: 8 weeks
Serious Adverse Device event incidence
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.
Time frame: 8 weeks
Anticipated Serious Adverse Device event incidence
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.
Time frame: 8 weeks
Unexpected Serious Adverse Device event incidence
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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.
Time frame: 8 weeks
Change in total number of lesions
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
Time frame: 4 weeks
Global Acne Grading System (GAGS)
To assess acne vulgaris severity by means of the Global Acne Grading System (GAGS) score, assessed by Investigator. Only for patients affected by acne vulgaris. The grading system score evaluates the acne severity from a minimum score of 0 (no acne) to \>39 (very severe acne).
Time frame: 8 weeks
Total Severity Score (TSS)
To assess the total number of patients having a decrease in the global severity of the disease by means of the Total Severity Score (TSS), assessed by Investigator. The scale evaluates of symptoms of each diseases (for folliculitis - pustule and inflammatory nodules; for acne vulgaris - comedones, papules, pustules, nodules, cysts, abscesses) from 0 (absent) to 3 (severe).
Time frame: 8 weeks
Treatment satisfaction questionnaire
To assess the patient satisfaction by means of the treatment satisfaction questionnaire, assessed by patient, providing their degree of satisfaction with the treatment on a four-point scale (very satisfied, satisfied, moderately satisfied, or not satisfied)
Time frame: 8 weeks
Investigator Global Assessment of Performance (IGAP)
To evaluate the global performance of Ialuxid® Gel by means of the Investigator Global Assessment of Performance (IGAP), assessed by Investigator, through photos taken at each visit. The scale evaluates the change on a 4 point scale from 1 meaning very good performance to 4 meaning poor performance)
Time frame: 8 weeks
Investigator Global Assessment of Performance (IGAS)
To evaluate the global safety of Ialuxid® Gel by means of the Investigator Assessment of Performance (IGAS) assessed by the Investigator, providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Time frame: 8 weeks
Patient Global Assessment of Performance (PGAS)
To evaluate the global safety of Ialuxid® Gel by means of the Patient Assessment of Performance (PGAS) assessed by the patient, providing the safety on a four point scale from 4 meaning poor safety to 1 meaning very good safety.
Time frame: 8 weeks
Dermatology Life Quality Index (DLQI)
To assess the quality of life by means of the Dermatology Life Quality Index (DLQI) score, assessed by patients, providing the impact the disease had on the subjects life in various scenarios from not at all to very much
Time frame: 8 weeks