Head Lice Treatment: Heading Off an Ancient Adversary · 2016. 8. 4. · •Transmission of lice typically occurs by direct head-to-head contact with an infested individual1,2 •

Wendy L. Wright MS, RN, APRN, FNP, FAANP, FAAN

Head Lice Treatment: Heading Off an Ancient Adversary

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Wendy L. Wright MS, RN, APRN, FNP, FAANP, FAAN

Head Lice Treatment: Heading Off an Ancient Adversary

Head Lice Treatment

Heading Off an Ancient Adversary

PP-SKL-US-0103 5/16

Centers for Disease Control and Prevention (CDC).

Presentation Outline

I. Head Lice Are With Us

II. Approaches to Head Lice Treatment

III. The Role of HCPs in Head Lice Management

IV. Educational Resources

2

Head Lice Are With Us

“Lice occur wherever there are humans.”1

Reference: 1. Lice (pediculosis). In: Paller AS, Mancini AJ, eds. Hurwitz Clinical Pediatric Dermatology. A Textbook of Skin Disorders of Childhood and Adolescence. 4th ed. New York, NY: Elsevier Saunders; 2011:424-427.

atology1

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Head Lice Infestation: A Common Pediatric Condition

• Pediculosis is the most prevalent parasitic infestation among humans1

• Head lice infestations are pervasive among school-age children in the United States2,3

• ~6-12 million infestations occur each year in children 3 to 11 years of age3

– More common in females4 • All socioeconomic groups are affected2,4

– Contrary to myth, “head lice prefer clean, healthy hosts”4

References: 1. Hodgdon HE, et al. Pest Manag Sci. 2010;66(9):1031-1040. 2. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365. 3. Centers for Disease Control and Prevention (CDC). http://www.cdc.gov/parasites/lice/head/epi.html. Accessed April 29, 2016. 4. Meinking T, et al. Infestations. In: Schachner LA, Hansen RC, eds. Pediatric Dermatology. 4th ed. Mosby Elsevier; 2011:1535-1583.

Photo Researchers

Getty Images/Peter Dazeley

4

Pediculus Humanus Capitis: A Closer Look at the Critter1

• The adult louse is 2-3 mm long (size of a sesame seed) – Usually tan to grayish-white; color

may vary (red when engorged with blood)

• The louse feeds by injecting small amounts of saliva into the scalp and sucking tiny amounts of blood every few hours

• Lice usually survive less than 1 day away from the scalp at room temperature

Reference: 1. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365. 5

CD

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The Life Cycle of the Head Louse1,2

Female lives 3-4 weeks

Lays ≤10 eggs per day

Eggs tightly attached to hair close to scalp

Eggs hatch in 7-12 days

Female lays first egg 1 or 2 days

after mating

Without treatment, the cycle may repeat every

3 weeks

Become adults 9-12 days after

hatching

3 nymph stages

1

2

3

References: 1. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365. 2. Meinking TL, et al. Infestations. In: Schachner LA, Hansen RC, eds. Pediatric Dermatology. 4th ed. Mosby Elsevier; 2011:1535-1583.

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Illustration by Penumbra Design Inc.

Transmission: Think Head-to-Head

• Transmission of lice typically occurs by direct head-to-head contact with an infested individual1,2

• Indirect spread via contact with personal items (combs, brushes, hats) is less likely but can occur1,2

• Itching is the most common symptom – It may take 4-6 weeks for itching to develop

in someone infested for the first time1

• In those with previous episodes, itching may develop within 48 hours3

– Excoriation, crusting, secondary bacterial infection may result from scratching1-3

References: 1. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365. 2. CDC. Head lice. http://www.cdc.gov/parasites/lice/head/epi.html. Accessed April 29, 2016. 3. Meinking TL, et al. Infestations. In: Schachner LA, Hansen RC, eds. Pediatric Dermatology. 4th ed. Mosby Elsevier; 2011:1535-1583.

Getty Images/Photodisc

Getty Images/Westend61

7

Careful Inspection Needed for Proper Diagnosis

A 10-year-old girl complained of scalp pruritus for several weeks. Nits (within white circle) were visible on hairs above the ear. Note the brown scaly fecal material below the hair line (black circle).

Photo © Bernard Cohen, MD. DermAtlas; http://www.dermatlas.org. 8

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Unhatched egg of a head louse, firmly cemented to hair shaft.

Nymphs, Nits, and Knowing What to Do

• Definitive diagnosis is made by finding a live adult louse or nymph on the scalp or head1,2

• Eggs attached >1 cm from the scalp are usually non-viable1

– In some warmer climates, viable eggs may be found several inches from the scalp1,3

– Close inspection is needed1,2

• Nit casings with egg inside may be tan to coffee color or darker; white or yellowish shells are non-viable4

• Nits and eggs may be confused with dandruff, fibers, scabs, hair casts, droplets of hair spray, plugs of desquamated cells, particles of dirt, or other insects1,3,5

References: 1. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365. 2. CDC. http://www.cdc.gov/.parasites/lice/head/diagnosis.html. Accessed April 29, 2016. 3. Lice (pediculosis). In: Paller AS, Mancini AJ, eds. Hurwitz Clinical Pediatric Dermatology. A Textbook of Skin Disorders of Childhood and Adolescence, 4th ed. New York, NY: Elsevier Saunders; 2011:424-427. 4. Meinking TL, et al. Infestations. In: Schachner LA, Hansen RC, eds. Pediatric Dermatology. 4th ed. Mosby Elsevier; 2011:1535-1583. 5. American Academy of Pediatrics. Pediculosis capitis (head lice). In: Kimberlin DW, Brady MT, Jackson MA, Long SS, eds. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015:597-601. 9

Direct and Indirect Costs Associated with Head Lice Are High

• Anecdotal reports from the 1990s estimated annual direct and indirect costs totaling $367 million, including consumer costs, lost wages, and school system expenses1

• Indirect costs include missed days from schools that use a “no nit” policy, lost wages for parents who must stay home with children, and costs of day care for parents who cannot miss work1,2

• Contributors to the expense of treating head lice include misdiagnosis leading to unneeded treatment; treatment failure due to misuse of pediculicides or other agents; and developing resistance, particularly to over-the-counter (OTC) pyrethroid agents1

• Twelve to 24 million school days are lost each year because of head lice3,4 • Some evidence suggests that parents treat an average of 5 times before

seeking help from a health care professional5

References: 1. Hansen RC, et al. Clin Pediatr. 2004;43(6):523-527. 2. West DP. Am J Manag Care. 2004;10(suppl):S277-S282. 3. Price JH, et al. J Sch Health. 1999;69(4):153-158. 4. Sciscione P, et al. J Sch Nurs. 2007;23(1):13-20. 5. Meinking TL, et al. Arch Dermatol. 2002; 138(2): 220-224. 10

Approaches to Head Lice Treatment

11

Typical Treatment Paradigm for Head Lice1

• Availability and awareness of OTC products; limited parent knowledge, poor perception of Rx choices

• Immediate access to OTC products (avoid delay in treating)

• Access to “trusted advisors”: school nurse or pharmacist

Treat On Their Own Contact HCP

46% are instructed to try OTC first

54% receive a prescription for an OTC product or traditional Rx

70% of Households

30% of Households

Reference: 1. Arbor Pharmaceuticals. Data on file (ICR Research; Excel Omnibus Studies H8824-26, I8823), July 2009. 12

Diagnosis: often by school nurse, parent,

or caregiver

OTC Prescription

Nix®b (permethrin, 1%) Lindane Shampoo2,d 1%

RID®c et al (pyrethrins with piperonyl butoxide)

Ovide®e (malathion, 0.5% lotion)

Other Ulesfia®f (benzyl alcohol, 5% lotion)

Natroba®g (spinosad, 0.9% suspension)

Sklice®h (ivermectin, 0.5% lotion)

Treating Head Lice: Many Choices1,a

b Nix® is a registered trademark of Insight Pharmaceuticals, LLC. c RID® is a registered trademark of Bayer HealthCare, LLC. d Lindane Shampoo is manufactured by Morton Grove Pharmaceuticals. Note: Lindane is currently recommended only as a second-line treatment.2 e Ovide® is a registered trademark of Taro Pharmaceuticals, U.S.A., Inc. f Ulesfia® Lotion is a registered trademark of Concordia Pharmaceuticals Inc. g Natroba® is a registered trademark of ParaPRO LLC. h Sklice Lotion is a registered trademark of Arbor Pharmaceuticals LLC.

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a For a review of treatment choices, see the American Academy of Pediatrics (AAP) 2015 clinical report.1

References: 1. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365. 2. CDC. http://www.cdc.gov/parasites/lice/head/treatment.html. Accessed May 24, 2016.

(recommended as second line treatment)d

Please see Important Safety Information for Sklice on slide 33

Prescription Lice Products Lindane

Shampoo,1%1,a Malathion, 0.5%

(Ovide)2

Benzyl alcohol, 5%

(Ulesfia)3

Spinosad, 0.9%

(Natroba)4

Ivermectin, 0.5%

(Sklice Lotion)5

Age indication

Use with caution in those <110 lb

Safety not shown <6 years

≥6 months ≥6 months

≥6 months

Dosage 1-2 oz depending on

hair length and density

2-oz bottles; apply enough to

wet hair and scalp

4-48 oz (varies with hair length)

Up to 120 mL (1 bottle)

depending on hair length

Up to 120 mL ( 4 oz tube)

Time of application

4 minutes; do not re-treat

8-12 hours; repeat

treatment in 7-9 days if lice

present

10 minutes; repeat

treatment after 7 days

10 minutes; repeat

treatment in 7 days if lice

present

10 minutes; tube is intended for

single use only; consult HCP

prior to re-treatment

References: 1. Lindane Shampoo [Prescribing Information]. Morton Grove, IL: Morton Grove Pharmaceuticals, 2007. 2. Ovide [Prescribing Information]. Hawthorne, NY: Taro Pharmaceuticals, 2013. 3. Ulesfia [Prescribing Information]. Bridgetown, Barbados, West Indies; Concordia Pharmaceuticals Inc., 2014. 4. Natroba [Prescribing Information]. Carmel, IN: ParaPRO, 2014. 5. Sklice Lotion [Prescribing Information]. 6. CDC. http://www.cdc.gov/parasites/lice/head/treatment.html. Accessed May 24, 2016. 14

There are no head-to-head studies comparing these products. a Lindane is currently recommended only as a second-line treatment.6

Please see Important Safety Information for Sklice on slide 33

Other Approaches

• Home remedies and “natural” products1

– Essential oils, plant extracts – Occlusive agents: mayonnaise, petroleum jelly,

tub margarine, Cetaphil®a cleanser

– Vinegar and vinegar-based products – The effectiveness of these products has not been evaluated in

randomized controlled trials, and their safety and efficacy are not currently regulated by the FDA

• Removal of nits and lice – Products such as dimethicone gel (LiceMD®b) and gel containing

citric acid, isopropanol, other ingredients (Lycelle®c)


a Cetaphil® is a registered trademark of Galderma Laboratories, LP. b LiceMD® is a registered trademark of Quantum Pharmaceuticals. c Lycelle® is a registered trademark of Mission Pharmacal Company.

Nitpicking Salons

• Nitpicking salons have opened in parts of the US (California, Florida, Texas, northeastern states) with some franchises1,2

• Advertise a “natural” or “chemical-free” approach to lice and nit removal

• Treatments may include “comb-outs” and application of controlled hot air1,3,4

• The industry is unregulated and quality of salons may vary significantly5

References: 1. LiceLifters. http://www.licelifters.com. Accessed April 29, 2016. 2. The Lice Place. http://www.theliceplace.com. Accessed April 29, 2016. 3. Goates B, et al. Pediatrics. 2006;118(5):1962-1967. 4. Bush SE, et al. J Med Entomol. 2011;48(1):67-72. 5. Kridel K. Chicago Tribune. http://articles.chicagotribune.com/2008-01-03/news/0801030116_1_head-lice-helpers-hair-fairies-harvard-university-public-health. Accessed April 29, 2016. 16

How Head Lice Cases Are Treated1

References: 1. Arbor Pharmaceuticals. Data on file (ICR Research; Excel Omnibus Studies H8824-26, I8823), July 2009. 2. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365.

Lice and Nit Removal Service

1%

Rx products 10%

Home Remedies and

Natural Products 16%

Nit Combing

10%

OTC products 57%

Don’t Know 6%

17

Factors contributing to OTC use include consumer awareness, ease of access, and recommendations by groups such as the AAP.2

Why Some Cases May Persist After Treatment

• If treatment appears to be ineffective, the problem may be misdiagnosis (no active infestation or misidentification)1-3

– Non-lice, non-nit debris may be mistaken for infestation2

– Other conditions may be mistaken for head lice3

• Contact or seborrheic dermatitis, eczema, psoriasis, insect bites, piedra

• Persistence of actual infestation may result from1 – Lack of adherence to the treatment regimen

(such as not using enough product to saturate the hair)

– Reinfestation (lice reacquired after treatment) – Lack of ovicidal or residual killing properties in the product

– Resistance of lice to the pediculicide

References: 1. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365. 2. CDC. http://www.cdc.gov/parasites/lice/head/diagnosis. Accessed April 29, 2016. 3. Meinking TL, et al. Infestations. In: Schachner LA, Hansen RC, eds. Pediatric Dermatology. 4th ed. Mosby Elsevier; 2011:1535-1583. 18

Treatment Resistance1

• None of the currently available pediculicides are 100% ovicidal

• Resistance has been reported with lindane, pyrethrins, permethrin, and malathion

• This is not unanticipated, as insects have been known to develop resistance to products over time

• The actual prevalence of resistance to particular products is not known and can vary regionally


Clinical Evidence of Permethrin Resistance1

• In 2009, 2 phase III, multicenter, randomized, investigator-blinded studies compared 0.9% spinosad without nit combing to 1% permethrin with nit combing in 1038 participants with active head lice infestations

• Results (Study 1 and Study 2, respectively), 14 days post-treatment: – 44.9% and 42.9% of subjects treated with permethrin were lice-free – 84.6% and 86.7% of subjects treated with spinosad were lice-free

• Most spinosad-treated participants required 1 application, whereas most permethrin-treated participants required 2 applications

Reference: 1. Stough D, et al. Pediatrics. 2009;124(3):e389-e395. 20

Declining Efficacy of Permethrin and Parallel Increase of kdr-type Mutations in the US1

21

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Kim 2011

Present Study Yoon et al. 2014

Hodgdon et al. 2010

Hodgdon et al. 2010

Kim 2011

Meinking et al. 2004

Brandenburg et al. 1986 Bainbridge et al. 1998

Carson et al. 1988 Taplin et al. 1986

DeNapoli et al. 1988

Reference: 1. Gellatly KJ, et al. J Med Entomol. 2016;53(3):653-659. Reproduced with permission of the Journal of Medical Entomology.

2014: Map of TI Mutation Frequency in 12 States1

Reference: 1. Yoon KS, et al. J Med Entomol. 2014;51(2):450-457. Reproduced with permission of the Journal of Medical Entomology. 22

2016: Expansion of the kdr Frequency Map in the US1

Reference: 1. Gellatly KJ, et al. J Med Entomol. 2016;53(3):653-659. Reproduced with permission of the Journal of Medical Entomology. 23

RAF = resistance allele frequency. kdr-type allele frequency map using mean % RAF values from head lice collected in the US, 2013-2015. Each collection site is color coordinated based on the mean % RAF of kdr-type mutations found: red is fully resistant (RAF=100%), orange (50%≤RAF<99%) is intermediate, and green is fully susceptible (RAF=0%).

As indicated by the red dots on the map below, 42 of the 48 states sampled (88%) showed a mean % RAF of 100%; the remaining 6 states (12%) had intermediate mean % RAF of 50%-98%

Frequency of kdr-type Mutations in the 6 States That Were Not 100% Resistant

Reference: 1. Gellatly KJ, et al. J Med Entomol. 2016;53(3):653-659. Reproduced with permission of the Journal of Medical Entomology. 24

MI = Michigan; NJ = New Jersey; ND = North Dakota; NM = New Mexico; OR = Oregon; NY = New York.

0.0%

60.3% 69.1% 71.7%

80.9% 86.6%

0%10%20%30%40%50%60%70%80%90%

100%

MI NJ ND NM OR NY

Mea

n %

Res

ista

nce

Alle

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Freq

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States

The Role of the HCP in Head Lice Management

25

AAP Issues a Call: Get More Involved in Head Lice Treatment1

• Historically, diagnosis of infestations by parents and other non-health care personnel, combined with easy availability of OTC pediculicides, essentially removed the HCP from the treatment process

• Emergence of resistance to available products and development of new products call for increased provider involvement in diagnosing and treating head lice

• HCPs should be knowledgeable about head lice infestations and treatments – They should take an active role as information resources

for families, schools, and community agencies – Instructions on the proper use of products should be carefully

communicated to families


Guidance on Managing Infestations

• Never initiate treatment without a clear diagnosis of living head lice1,2

– Check all household members, other close contacts, and treat if active infestation is found2

• In recommending treatment products, consider1

– Effectiveness – Safety – Ease of use – Cost – Local patterns of resistance (if known)

• 1% permethrin or pyrethrins can be used to treat active infestations unless resistance has been proven in the community1

• If treatment does not seem to be working, possible causes include incorrect use or resistance2

References: 1. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365. 2. CDC. http://www.cdc.gov/parasites/lice/head/treatment.html. Accessed April 29, 2016. 27

Finding Information on Resistance

• There have been reports of resistance to OTC and Rx head lice products; however, the actual prevalence of resistance is not known1

• To check on resistance patterns in your own area, consult local or state public health departments and university resources if available


Keeping Kids in School

• The AAP and National Association of School Nurses state: No healthy child should be excluded from school or allowed to miss school time because of head lice1,2

• “No-nit” policies for return to school should be abandoned1,2

• School-based head lice screening programs have not had a significant effect on incidence of head lice in schools and are not cost-effective2

• School nurses, in concert with other HCPs, should become involved in helping school districts develop evidence-based policies1

References: 1. Smith S, et al. http://www.nasn.org/PolicyAdvocacy/ PositionPapersandReports/NASN PositionStatementsFullView/ tabid/462/smid/824/ArticleID/934/ Default.aspx. Accessed April 29, 2016. 2. Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365.

29

Areas of Involvement for the HCP

• Encourage parents to consult an HCP when seeking treatment of head lice infestation

• Take an active role in diagnosis and management of pediculosis and helping families sort through the treatment choices

• Develop collaborative relationships with school nurses, school administrators, pharmacists, public health officials, and their professional associations

• Educate families and the community to promote knowledgeable care and dispel myths and misunderstandings about head lice

54

Helpful Resources for Parents and Practitioners on Head Lice

• Centers for Disease Control and Prevention – http://www.cdc.gov/parasites/lice/head/index.html

• National Association of School Nurses, Policy Statement (2016) – http://www.nasn.org/PolicyAdvocacy/PositionPapersandReports/

NASNPositionStatementsFullView/tabid/462/smid/824/ArticleID/934/ Default.aspx

– American Academy of Pediatrics, 2015 Clinical Report – Devore CD, et al. Pediatrics. 2015;135(5):e1355-e1365.

• Publication of Phase III trials for Sklice Lotion – Pariser D, et al. N Engl J Med. 2012;367(18):1687-1693.

• “The child with pediculosis capitis” – Yetman RJ. J Pediatr Health Care. 2015;29(1):118-120. – Publication of the National Association of Pediatric Nurse Practitioners

55

Head Lice Treatment

Heading Off an Ancient Adversary

PP-SKL-US-0103 5/16

Centers for Disease Control and Prevention (CDC).

Important Safety Information for Sklice Lotion

To prevent accidental ingestion, Sklice Lotion should only be administered to pediatric patients under the direct supervision of an adult.

The most common adverse reactions (incidence <1%) include conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation.

32

Full Prescribing Information for Sklice Lotion is available at www.Sklice.com

Head Lice Treatment: Heading Off an Ancient Adversary · 2016. 8. 4. · •Transmission of lice typically occurs by direct head-to-head contact with an infested individual1,2 •

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