Affiliation:
1. Department of Otolaryngology-Head and Neck Surgery, Shamir Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel-Aviv, Israel
2. Clinical Pharmacology and Toxicology Unit, Shamir Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel-Aviv, Israel
Abstract
To evaluate Tonsitin (10% DL-lactic acid) safety, tolerability, and efficacy, as a treatment for recurrent tonsillitis (RT) in children. This is a clinical prospective, randomized, double blind pilot study, to evaluate the safety, tolerability and efficacy of Tonsitin in healthy children with RT. Safety evaluated in terms of adverse events (AEs), tolerability in terms of compliance, and efficacy in terms of tonsils’ size and frequency of tonsillitis, and quality of life. The study included 51 children. The treatment regimen was tolerable among the participants. Six children experienced AEs, but mostly mild. Tonsil size declined in both groups, but these results did not reach statistical significance. Tonsillitis episodes’ frequencies were random and not significant. Tonsitin treatment was found to be feasible in the clinical setup and was well tolerated, and appears to be safe. Study efficacy results did not reach statistical significance.
Funder
Yali Pharmaceuticals Ltd.