Abametapir lotion, 0.74% demonstrates high elimination rates of head lice with a single application in Phase 3 trials
Lydie Hazan, MD1; Robert S Haber, MD2; Michael Husseman, MD3; Katie Shepherd4; Sharon Hanegraaf5; Tiina Ahveninen5; Lisa Jenkins6; Hugh Alsop5; Vernon M Bowles, PhD7

1Axis Clinical Trials, Los Angeles, CA; 2Case Western University School of Medicine, Cleveland, OH; 3Wee Care Pediatrics, University of Utah School of Medicine, Salt Lake City, UT;  
4The Shepherd Institute for Lice Solutions, West Palm Beach, FL;  5Hatchtech Pty Ltd, Melbourne, Australia; 6Virtual Regulatory Solutions, Audubon, PA; 7University of Melbourne, Melbourne, Australia

Results

Introduction

Objective

Methods 

Financial Support:  This study was funded and supported by Hatchtech Pty Ltd, Melbourne, Australia. DRL Publication #783

¾ Successful treatment of head lice infestations may be hampered by limited ovicidal efficacy of current treatments1, increasing resistance to commonly used treatments2, and poor 
adherence to 2-application treatment regimens.

¾ Abametapir lotion, 0.74%, contains the active ingredient abametapir, a compound with a new mode of action3 being developed for the single-application treatment of head lice 
infestation.

The objective of the current studies was to evaluate the efficacy of a single 10 minute application of abametapir lotion, 0.74% for the treatment of head lice infestation in subjects 6 
months of age and older.

¾ Two randomized, double-blind, vehicle-controlled, parallel-group, multi-center studies were conducted in subjects aged ≥ 6 months with active head lice infestations along with 
household members with ≥ 1 live louse. 

¾ Households were equally randomized to receive abametapir lotion, 0.74% or vehicle.

¾ Product was applied to dry hair for 10 minutes and rinsed with water. No nit combing was performed. Following treatment, subjects were inspected for live lice on days 1, 7, and 14.

¾ Treatment success was defined as being louse-free at all post-baseline visits through day 14. 

¾ Enrollment included a total of 704 subjects with comparable demographics in each study.

¾ For all subjects treatment success was 88.2% (165/187) and 81.0% (132/163) with abametapir lotion, 0.74% for the two studies, respectively, compared with 62.0% (119/192) and 
60.5% (98/162) for the vehicle groups (both P<.001) (Table1). 

¾ The most common treatment emergent adverse events were erythema, rash, and skin burning sensation (Table 2).

¾ A single, 10-minute application of abametapir lotion, 0.74% was effective in treating active head lice infestation within 14 days in subjects 6 months or older. 
¾ In this study, the most common adverse events were erythema, rash, and skin burning (range 2.6% to 4.0%) and there were no serious adverse events.

References

1. Mumcuoglu KY, Effective treatment of head louse with pediculicides. J Drugs Dermatol. 2006;5:451-452.
2. Durand RS, Bouvresse s, Berdjane Z, et al. Insecticide resistance in head lice: Clinical parasitological and genetic aspects. Clin Microbiol Infect. 2012;18:338-344.
3. Van Hiel MB, Breugelmans B, Pagel CM, et al. The ovicidal, larvacidal and adulticidal properties of 5,5’-dimethyl-2,2’-bipyridyl against drosophila melanogaster. PLOS One. 

2012;7:e49961.

Table 2.  Adverse Events Occurring in ≥ 1% of the Abametapir Lotion, 0.74% Group and at a Greater 
Frequency than in the Vehicle Group (Studies 1 & 2)

Adverse Reactions
Abametapir Lotion, 0.74%

N=349 
Vehicle Lotion

N=350
Erythema 14 (4.0%) 6 (1.7%)
Rash 11 (3.2%) 8 (2.3%)
Skin Burning Sensation 9 (2.6%) 0 (0.0%)
Contact Dermatitis 6 (1.7%) 4 (1.1%)
Vomiting 6 (1.7%) 2 (0.6%)
Eye Irritation 4 (1.2%) 2 (0.6%)
Hair Color Changes 3 (1.0%) 0 (0.0%)*Overall Treatment Success defined as being louse-free at all post-baseline visits through day 14

Table 1.  Overall Treatment Outcome by Study & Treatment Group
Study 1
% (N)

Abametapir Lotion, 0.74%
(N=187)

Vehicle Lotion
(N=192)

Treatment Success 88.2% (165)* 62.0% (119)

Treatment Failure 11.8% (22) 38.0% (73)
Study 2
% (N)

Abametapir Lotion, 0.74%
(N=163)

Vehicle Lotion
(N=162)

Treatment Success 81.0% (132)* 60.5% (98)

Treatment Failure 19.0% (31) 39.5% (64)

Conclusions


	FC17PosterPromiusHazanAbametapirLotion.74.pdf