Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study

Abstract

BackgroundDue to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo.MethodsThis randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014—June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10.ResultsCure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p < 0.001, 2-sided, 1-sample, chi-square test) with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%). Both products were safe and well tolerated, offering good esthetical effects.ConclusionThis study showed that substance-based medical devices (including the tested mineral oil shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because of the physical mode of action.Trial RegistrationGerman Clinical Trials Register (DRKS) DRKS00009753 and EudraCT database 2014-002918-23

Lindane Shampoo for Head Lice Treatment among Female Secondary School Students in Jeddah, Saudi Arabia: An Interventional Study

“…In addition, the failure of current chemical treatments to kill lice embryos in eggs, the environmental and food safety concerns posed by these treatments, and their potential toxicity to users necessitate the development of safe alternative treatment methods that can effectively kill adult lice and eggs via new modes of action [15,16], Other causes for the development of resistance to existing pediculicides include the persistence of pediculicide residue on hair, exposure of lice to sub-therapeutic concentrations, and inadequate concentration levels [5,6]. Numerous studies of the different types of head lice treatments have revealed that commercial pediculicides are ineffective in treating head lice infestations in students [12][13][14][17][18][19]. genetic mutations in the lice, which we plan to investigate in future studies.…”

Investigating the Efficacy of Sumac Topical Solution Against Permethrin-resistant Human Head Lice

“…Grade 2 or medium (10 to 25 nit or live nymphs/lice); 4. Grade 3 or severe (more than 25 nit or live nymphs/lice) [25,30]. All examinations were performed 4 times; once before the treatment (day zero) and 3 times after the start of treatment (days 4, 10, 14).…”

“…The inclusion criteria included avoiding depriving patients of routine treatment, patients who had used permethrin treatment twice and more consecutively (with at least 14 days interval) according to the correct instructions (on the first and 7 th day) and did not respond to treatment, and yet they had at least grade 1 infection (5-9 nit or live nymphs/lice); they were selected as subjects of the study according to the severity of the contamination [25]. Although the second line of treatment is based on Lindane therapy, the resistance to Lindane is also very high [2,8].…”

“…History of diseases related to immune deficiency; 5. pregnancy; 6. Participation in any clinical trials within the past 4 weeks or previous participation in this clinical trial [25,26]. Obviously, the patients who did not want to continue the cooperation or did not use the medicine in accordance with its correct instructions (the treatment for less than twice every 3 sequential days), or the patients, who used another anti-lice drug simultaneously with the treatment were excluded from the study.…”

Safety, Efficacy, and Physicochemical Characterization of Tinospora crispa Ointment: A Community-Based Formulation against Pediculus humanus capitis

“…The hair was divided into 4 quadrants by a plastic head lice comb. Next, the hair on each quadrant was combed 6 times starting from the scalp and ending at the hair tips [ 21 ]. The number of lice collected was counted.…”