Abstract
The present clinical trial was conducted to obtain additional data for the safety and efficacy of a head lice shampoo that is free of silicone compared with an anti-head lice product containing dimethicone. Both products act by a physical mode of action. This randomized, investigator-blinded, controlled clinical study was conducted between July and November 2016 in households of two villages (Abou Rawash and Shandalat) in Egypt. Children older than 2 years with an active head lice infestation were treated with either a shampoo-based head lice treatment containing neem extract (Licener (R)) or dimethicone (Jacutin (R) Pedicul Fluid) on day 1 and additionally on day 9. Assessment for living lice by combing was conducted before and 1-2 h after treatment and on days 5 and 13. The main objective was to demonstrate a cure rate of the test product of at least 85% after a single application (day 5 and 9). Secondary objectives were to scrutinize patient safety and satisfaction as well as cure rates on day 13 after two treatments and the evaluation of ovicidal and licicidal efficacies of the products. Sixty-one children in the test-group (Licener (R)) and 58 children in the reference group (Jacutin (R) Pedicul Fluid) were included in this study. The test product and the reference product were very well tolerated. Both products exceeded the objective of cure rates of over 85% after single treatment (test group 60/60 = 100%; 95% CI = 94.04-100.00%; reference group 54/57 = 94.74%; 95% CI = 85.38-98.90%; p = 0.112; CI by Clopper-Pearson) and after two treatments (test group 58/58 = 100%; 95% CI = 93.84-100.00%; reference group 52/54 = 96.30%; 95% CI = 87.25-99.55%; p = 0.230) with higher cure rates and non-inferiority for the test product. The combined success rate shows significant superiority of the test product against the reference product (test group 58/58 = 100%; 95% CI = 93.84-100.00%; reference group 49/54 = 90.7%; 95% CI = 79.70-96.92%; p = 0.024). The test product showed higher ovicidal efficacy than the reference product. Thus, the present study demonstrates that a single treatment with a head lice product like Licener (R) can be sufficient to eliminate a head lice infestation.