Performance and Safety of the Medical Device Ialuxid Gel in the Treatment of Mild-Moderate Acne Vulgaris: An Open-Label, Noncomparative Multicentre Interventional Clinical Trial.

BACKGROUND

Medical literature shows there is no ideal treatment for acne, but topical therapies like benzoyl peroxide, retinoids, and antibiotics have proven to improve mild-moderate cases. Replacing benzoyl peroxide (potentially irritating) with hydrogen peroxide has already been suggested in the medical literature.

AIMS

We investigated a medical device, a proprietary combination of hyaluronic acid, hydrogen peroxide, and glycine in mild-moderate acne vulgaris.

METHODS

Patients of both sexes between ≥ 18 and ≤ 45 years old, with a Global Acne Grading System score ≤ 30, were included. Exclusion criteria were dermal systemic or infectious diseases; allergy to the tested product; pregnant or lactating women; treatment for acne 30 days before baseline; and previous facial aesthetic surgery. Forty patients were treated for 8 weeks several times a day with the tested product and visited at baseline, week 2, week 4, and week 8. Outcomes were decreasing the total number of lesions and the Global Acne Grading System Severity Score, Investigator Global Assessment of Performance with photographs evaluation in blind, Dermatology Life Quality Index, and the Treatment Satisfaction Questionnaire. Adverse events were collected for safety.

RESULTS

A 2-fold decrease in the number of lesions at the final visit (-56.3%, p < 0.001). The remaining outcomes evidenced a statistically significant reduction at the final visit. Only 8 adverse events (all mild and related to the tested device) were reported.

CONCLUSIONS

Results and optimal safety demonstrate that the tested product has a clinical benefit and could be associated with retinoids, as first choice for mild to moderate acne.

TRIAL REGISTRATION

Clinicaltrial.gov as NCT05345093.