An interventional study of Ialuxid gel in Acne Vulgaris and Folliculitis, sponsored by BMG Pharma. Completed at 1 site in Romania. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by BMG Pharma · Not applicable, Interventional, and Treatment
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.
Patients diagnosed with acne vulgaris, and folliculitis.
a. Only for patients with acne vulgaris: mild to moderate Global Acne Grading Scale score (≤ 30).
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.).
twenty-two patients affected by acne vulgaris; twenty-two patients affected by folliculitis.
Device: Ialuxid gel
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.
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
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
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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