Abametapir lotion, 0.74%, a novel therapy for the treatment of head lice,  
pooled safety results from 11 trials, in children as young as 6 months

Lydie Hazan, MD1; David Cardona, MD2; Sharon Hanegraaf3; Tiina Ahveninen3; Hugh Alsop3; Vernon M Bowles, PhD4;
1Axis Clinical Trials, Los Angeles, CA; 2Universal BioPharma Research Institute Inc., Dinuba, CA; 3Hatchtech, Melbourne, Australia; 4University of Melbourne, Melbourne, Australia;

Results 

Introduction

Abametapir lotion, 0.74% is being developed for the single application treatment of 
head lice infestation. The active ingredient is a novel compound, abametapir. 
Abametapir lotion, 0.74% has been tested in 11 clinical trials, including 6 trials with 
pediatric subjects.  

Objectives

¾ To evaluate the clinical safety results in children as young as 6 months following 
exposure to abametapir lotion 0.74%.

¾ A total of 1372 subjects were evaluated in 11 clinical studies of abametapir lotion, 
0.74% including 6 studies with a total of 676 pediatric subjects (aged 6 months to 17 
years).

Methods 

¾ These 6 trials included one phase 2b trial, one phase 2 ovicidal efficacy trial, two open-
label phase 2 PK trials of maximal use, and two phase 3 vehicle-controlled trials.

¾ Across all trials, subjects ranged in age from 6 months to 60 years and exposure times 
ranged from 10 minutes to 20 minutes.

¾ Of the 905 subjects exposed to study treatment for 10 minutes, 483 received 
abametapir lotion, 0.74% and 422 received vehicle lotion.

¾ Safety assessments included vital signs, physical examination, clinical laboratory tests, 
and adverse events (AEs).

¾ The most frequently reported treatment-emergent AEs for pediatric subjects were in 
the system organ class of Skin and Subcutaneous Tissue Disorders, primarily 
erythema, rash, skin burning sensation, and contact dermatitis. 

¾ TEAEs were similar for adult and pediatric subjects.

¾ The majority of AEs were mild and there was no evidence of an age-related effect. 

¾ The two maximal-use pediatric trials had study drug exposure ranging from 3.3 g to 
200.8 g, and reported 14 AEs (23.3%) (Table 1).

¾ In the two phase 3 trials, AEs were reported by 24.4% subjects using abametapir 
lotion, 0.74% and 18.6% subjects using vehicle (Table 2). One serious AE, unrelated 
to study treatment, was reported in the vehicle group.

¾ There were no deaths, no discontinuations due to AEs and no clinically meaningful 
changes in vital signs, physical exams or laboratory tests in any of these trials.

Conclusions

¾ In 11 clinical studies of abametapir lotion, 0.74% for the treatment of 
head lice in subjects ranging in age from 6 months to 60 years, AEs 
were mild, not age-related, and primarily in the system organ class of 
Skin and Subcutaneous Tissue Disorders.

Financial Support: This study was funded and supported by Hatchtech Pty Ltd, Melbourne, Australia. DRL Publication #796

Table 2. Summary of AEs in the SOC of Skin and Subcutaneous Tissue Disorders Reported in Two 
Phase 3 Trials and One Phase 2 Ovicidal Efficacy Trial

Table 1.Summary of Adverse Events in the SOC of Skin and Subcutaneous Tissue Disorders in Phase 
2 PK Trials

SOC Preferred Term
Study Ha02-003

Study 
Ha03-003

Study 
Ha03-004

ABA 0.74%
n = 49

Vehicle
n = 47

ABA 0.74%
n = 22

ABA 0.74%
n = 38

Overall Incidence 13 (26.5) 27 (57.4) 6 (27.3) 8 (21.1)

Skin & Subcutaneous 
Tissue Disorders

7 (14.3) 19 (40.4) 4 (18.2) 5 (13.2)

Pruritus 2 (4.1) 18 (38.3) 1 (4.5) 0
Erythema 0 2 (4.3) 0 0
Dermatitis 0 0 1 (4.5) 0
Dermatitis contact 3 (6.1) 0 0 2 (5.3)
Dermatitis allergic 2 (4.1) 0 0 0
Rash 0 0 1 (4.5) 0
Exfoliative rash 1 (2.0) 0 0 0
Dry Skin 0 1 (2.1) 0 0
Rash macular 0 0 0 1 (2.6)
Rash popular 0 0 0 1 (2.6)
Skin disorder 0 0 1 (4.5) 0
Skin irritation 0 0 0 1 (2.6)

SOC Preferred Term

Ha03-001 Ha03-002 Ha03-008
ABA 0.74%

N = 186
n (%) 

Vehicle
N = 188

n (%) 

ABA 0.74%
N = 163

n (%) 

Vehicle
N = 162

n (%) 

ABA 0.74%
N = 25
n (%) 

Vehicle
N = 25
n (%) 

Overall Incidence 37 (19.9) 32 (17.0) 48 (29.4) 33 (20.4) 6 (24.0) 4 (16.0) 
Skin & Subcutaneous 
Tissue Disorders

16 (8.6) 14 (7.4) 32 (19.6) 23 (14.2) 5 (20.0) 3 (12.0) 

Erythema 4 (2.2) 0 10 (6.1%) 6 (3.7) 0 1 (4.0) 
Skin exfoliation 1 (0.5) 0 2 (1.2) 8 (4.9) 0 0

Skin burning sensation 0 0 9 (5.5) 0 0 0

Rash 2 (1.1) 0 7 (4.3) 8 (4.9) 4 (16.0) 2 (8.0) 
Pruritus 1 (0.5) 8 (4.3) 2 (1.2) 2 (1.2) 1 (4.0) 0
Dermatitis 0 0 0 3 (1.9) 0 0

Dry skin 0 0 0 3 (1.9) 0 0

Hair color changes 0 0 3 (1.8) 0 0 0

Urticaria 0 0 0 2 (1.2) 0 0

Rash pruritic 0 0 0 1 (0.6) 0 0

Skin plaque 0 1 (0.5) 0 1 (0.6) 0 0

Swelling face 0 0 0 1 (0.6) 0 0

Dermatitis contact 6 (3.2) 4 (2.1) 0 0 0 0

Rash erythematous 0 1 (0.5) 0 0 0 0

Skin disorder 2 (1.1) 0 0 0 0 0

Skin irritation 2 (1.1) 0 0 0 0 0

Note:  ABA 0.74% = abametapir lotion, 0.74%

Note:  ABA 0.74% = abametapir lotion, 0.74%


	FC17PosterPromiusHazanAbametapirLotionSafety6Months.pdf