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


METHODS
This 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.


RESULTS
Cure 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.


CONCLUSIONS
This 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.


BACKGROUND
German Clinical Trials Register (DRKS) DRKS00009753 and EudraCT database 2014-002918-23.
Cardiosec Clinical Research GmbH, Dalbergsweg 21, 99084, Erfurt, Germany.
Luise
L
Wolf
Oystershell Laboratories, Booiebos 24, 9031, Drongen, OVL, Belgium.
Frank
F
Eertmans
Cardiosec Clinical Research GmbH, Dalbergsweg 21, 99084, Erfurt, Germany.
Doerte
D
Wolf
Oystershell Laboratories, Booiebos 24, 9031, Drongen, OVL, Belgium.
Bart
B
Rossel
Adriaens Consulting, Bellemdorpweg 95, 9881, Bellem, OVL, Belgium.
Els
E
Adriaens
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000818:Animals; D002648:Child; D002675:Child, Preschool; D005260:Female; D006203:Hair Preparations / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D007306:Insecticides / Q000008:administration & dosage / Q000009:adverse effects; D010373:Lice Infestations / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008899:Mineral Oil / Q000008:administration & dosage* / Q000009:adverse effects*; D010374:Pediculus / Q000187:drug effects*; D012536:Scalp Dermatoses / Q000188:drug therapy; D016896:Treatment Outcome; D055815:Young Adult
D006203:Hair Preparations; D007306:Insecticides; D008899:Mineral Oil