Medical Device Ialuxid Gel Is Successful in Treating Mild to Moderate Acne

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Real-world performance and safety data on the medical device Ialuxidgel (MDIC) developed by BMG Pharma S.p.A. has been published.¹ Patients with mild to moderate acne saw a 56% reduction in lesions after 8 weeks of treatment. The product combines hyaluronic acid, hydrogen peroxide, and glycine as a less irritating, proprietary therapy.

The open-label, noncomparative, multicenter, interventional trial (NCT05345093) took place at 3 sites in Romania (SC Salvosan Ciobanca in Zalău, Darzas Esthetic in Oradea, and Nova-Clin Medical Research Center in Timişoara). Thirty-six participants were recruited from November 2022 to September 2023. Patients were between ≥ 18 and ≤ 45 years old and all had a Global Acne Grading System (GAGS) score of ≤ 30.

The treatment period lasted 8 weeks with the product being self-administered 2 to 3 times a day. Patients stopped all other dermatological procedures and treatments to prepare for the study. Investigator visits took place at baseline and weeks 2, 4, and 8.

The primary outcome was the reduction in total lesions compared to day 0. This is the change that is “constantly monitored by every physician and immediately indicated by patients during the treatment period,” according to the authors. Secondary outcomes were measured at day 28 and day 56. Disease severity and product evaluation was measured using the GAGS, Total Severity Score (TSS), Investigator Global Assessment of Performance (IGAP), Dermatology Life Quality Index (DLQI), and the Treatment Satisfaction Questionnaire.

After 28 days, the number of acne lesions decreased by -39% (p < 0.001). At the final visit, a 2-fold decrease in the number of lesions was observed(−56.3%, p < 0.001). Strong reductions in GAGS score from baseline were noted at day 28 (−30.7%, p = 0.001) and day 56 (−49.2%, p < 0.001). Statistically significant changes in TSS from baseline were also observed at day 28 (−42.8%, p = 0.002) and day 56 (−59.5%, p < 0.001).

The Investigator Global Assessment of Performance (IGAP) was used to categorize the photographs that were taken at each visit. Very good performance was indicated in over 50% of the participants. Only 1 patient had a “poor” performance on a 4-point scale.

Patient quality of life also improved throughout the entire study (−78.6%; p < 0.001). The mean DLQI values decreased from 7.53 to 1.61. Most of the patients also had a high degree of treatment satisfaction according to the questionnaire. More specifically, 63.9% were very satisfied, 8.3% were satisfied, and 27.8% were moderately satisfied.

Eight adverse effects of irritation and pruritus were reported but all were mild and resolved by the end of the trial. All were transient application-site reactions and none were serious. There were also no cases of photosensitization.

One of the most common treatments for mild to moderate acne is benzoyl peroxide but is known for potentially causing irritation and dryness of the skin.² Because of this, recent literature has explored hydrogen peroxide as a substitution, when used with other ingredients. In this formulation, the hyaluronic acid provides soothing and reparative action while the glycine strengthens the barrier. The MDIC had similar results in lesion reduction when compared to benzoyl peroxide as the benchmark.

“Our intention was to provide a real-life snapshot of the routine dermatology practice carried out by specialist physicians in their outpatient clinics, reporting the safety and potential improvement in efficacy when administering the medical device MDIC gel to patients with mild to moderate acne,” the authors concluded.

References 

1. Stefancu ME, Barattini DF, Botnaru I, Vizman C, Stucchi L, Barattini L. 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. J Cosmet Dermatol. 2025;24(3):e70084. doi:10.1111/jocd.70084

2. Ives, T. J. (1992). Benzoyl Peroxide: This OTC medication, a mainstay for acne treatment, remains on the market while experts study implications of carcinogenicity tests in animals. American Pharmacy. 32(8), 33-38.