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Teclabsinc.comPharmacology & Pharmacy, 2013, 4, 266-273
doi:10.4236/pp.2013.42038 Published Online April 2013 (http://www.scirp.org/journal/pp)
Evaluation of the Efficacy and Safety of 1% Sodium
Chloride (LiceFreee Spray) against 1% Permethrin Crème
Rinse on Head Lice Infested Individuals
Lidia Serrano1, Lorraine S. Decesar1, Loan Pham2*
1South Florida Family Health and Research Centers, Plantation, USA; 2Carmago Pharmaceutical Services, Cincinnati, USA. Email: *LPham@camargopharma.com Received January 21st, 2013; revised March 3rd, 2013; accepted April 16th, 2013 Copyright 2013 Lidia Serrano et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT
Head lice are a public health issue, and resistance to available over-the-counter pediculicides is a concern. The objective
of this randomized study was to evaluate the pediculicidal activity and safety of 1% Sodium Chloride spray (0.1709 M),
(LiceFreee Spray®) compared to the current recommended treatment for head lice with 1% Permethrin Crème Rinse.
Forty-two subjects were randomized equally into Sodium Chloride or Permethrin group. Products were applied to hair
according to the label instructions. After application of the products at Day 1 and Day 8, pediculicidal efficacy and
safety were assessed at Day 1, Day 8 and Day 15. Second treatment was only applied on Day 8 to individuals with ob-
served live lice using the same products and protocols as Day 1. Proportion of lice free subjects per group, the reduction
in number of live lice per head and adverse effects were recorded after each visit. The results showed significantly
higher pediculicidal activity for Sodium Chloride spray (85%) as compared to Permethrin (45%) at Day 15 (p < 0.05).
Similar numbers of lice per head (21.76 range 10 to 68 versus 21.29 range 10 to 60 for Sodium Chloride and Permethrin
groups, respectively) were observed for individuals at Day 1. At Day 15, lice per head infested reduced to 0.55 ± 1.50 in
Sodium Chloride spray group compared to 5.45 ± 7.91 in the Permethrin group (p < 0.01). No serious adverse effects
were observed in both groups. Sodium Chloride spray had superior efficacy to 1% Permethrin Crème Rinse in treating
head lice and is a safe and excellent alternative to the current recommended treatment.
Keywords: Head Lice; Sodium Chloride; LiceFreee Spray®; Nix®; Permethrin
mia. Secondary bacterial infections can complicate the course of the infestation with Staphylococcus aureus the Pediculosis capitis caused by Pediculus humanus capitis most commonly implicated pathogen in this setting and has been recognized as an issue from the antiquity, and can lead to impetigo, cellulitis, pyoderma and abscess currently remains a common health concern. The tradi- formation [3-5]. The consequences of a head lice infesta- tional perception of head lice as a parasitosis exclusively tion can also result in psychological frustration for both associated with schoolchildren of low socioeconomic parents and children. In the USA alone, pediculosis capi- status is challenged by the facts that pediculosis capitis is widespread throughout the world and does not discrimi- tis is the most prevalent parasitic infestation of children nate on socioeconomic status grounds [1,2]. It primarily with 6 - 12 million children infested and needing treat- occurs in pre-school or elementary school age children ment for head lice each year. Head lice infestation also and those living in the same house, although it can be accounts for 12 - 24 million lost school days and $4 - $8 found in refugees, urban slums, jail inmates, orphanages, billion in economic loss due to missed workdays by par- and fishing communities . The prevalence worldwide ents staying home with their children . varies from 0.7% to 59% and is higher in girls and Parents or non-health care professionals diagnose a women. Having a head lice infestation is annoying, can head lice infestation by observing a louse crawling on the lead to pruritus, sleeplessness, and in extreme cases, ane- scalp or more frequently, observation of the nits on the hairs at the nape of the neck or behind the ears . Trans- mission of head lice is mainly by direct head-to-head Copyright 2013 SciRes. PP
Evaluation of the Efficacy and Safety of 1% Sodium Chloride (LiceFreee Spray) against 1% Permethrin Crème Rinse on Head Lice Infested Individuals contact with infested persons, particularly with children Board Inc. (IRB # Lf 001-0011) and was conducted in in the same school class, team or sharing playground. accordance with Good Clinical Practices and with the Fomite routes are less frequent and involve combs, hats, principles outlined in the Declaration of Helsinki. The towels, fabrics and warm air movements [8,9]. study was registered with ClinicalTrials.gov Protocol Removal of the head lice includes traditional physical Registration System ID number NCT01514513 and all methods (plucking off head lice etc.), the use of coating study treatments with follow up assessments were per- gels, oral medication and the application of chemicals to formed by the authors listed residing at South Florida the hair. Using pediculicides is the most frequent method. Family Health Research Center, 6971 West Sunrise Blvd., Pediculicides have shown effectiveness in reducing head lice infestation in populations globally . Normally, Individuals, aged 4 years or older, having a single pediculicidal treatment has to be applied on two occasions place of residence, diagnosed with an active head lice with 7 - 10 days in between, as the first dose of pediculi- infestation of at least 10 live lice at the Screening visit cides primarily kill nymphs and adult lice, while their and a presence of nits were eligible for inclusion in this ovicidal activity is generally poor. The time gap between study. The subjects agreed to not use a lice comb, or any treatments allows surviving eggs to hatch and the newly other pediculicides or medicated hair grooming products hatched nymphs subsequently be killed by the second for the duration of the study (through Day 15 visit). Fur- application . Until recently, topical agents such as thermore, parents and other family members of a child permethrin, allethrin, lindane or benzyl benzoate were were also screened for head lice. If other household still among the favorites. However, resistance to pedicu- members were found to have head lice and were eligible, licides has been reported in many areas of the United they were either enrolled in the study or were treated States as well as all around the world [10-12]. For exam- with the same product and in the same manner as study ple, reported efficacy of permethrin to head lice was re- duced from as high as 97% - 99% before 1999 to as low participants. All the participants of the study and where as 10% - 72% after 1999 . Importantly, several recent appropriate their legal guardian were explained the studies have revealed an increasing trend of simultaneous study’s procedures and signed informed consents. resistance against multiple agents including lindane, phe- Subjects using any form of head lice treatment for at nothrin and permethrin suggesting over-the-counter com- least four weeks or any topical medication for a period of mercially available insecticidal products may become in- 48 hours prior to the Screening visit (Day 1) were not effective [5,8,10]. Prescription-only products containing eligible for inclusion in the study. Individuals were also synthetic compounds, such as malathion and carbaryl, not eligible for participation if taking systemic or topical have not been established well by controlled trials in medications (including antibiotics), or suffering from term of safety and effectiveness for children less than 6 visible skin/scalp condition at the treatment sites, of years old (malathion) or raised the concerns of possible which in the opinion of the investigative personnel would carcinogenic effects (carbaryl) [10,13]. However, it has interfere with the evaluation of the test products. Anyone been suggested that resistance is starting to develop to who was allergic or sensitive to ragweed or any ingredi- this group also [5,14]. Therefore, alternative drugs for ent in either test product, pregnant or nursing, who did treatment of head lice are needed having the require- not understand the subject requirements for study par- ments of safety, high effectiveness, available OTC and ticipation and/or exhibited poor compliance with the re- quired visits were also excluded from the study. The primary objective was to compare the efficacy and Subjects could withdraw from study treatment at any safety of a one percent solution of Sodium Chloride time at their own request, or at the discretion of the in- (0.1709 M), against 1% Permethrin Crème Rinse, the vestigators for safety, behavioral or administrative rea- treatment of choice by the National Guideline Clearing- house , on subjects with head lice immediately fol- lowing the initial application at 7 (Day 8), and 14 (Day 2.2. Study Design
15) days following the initial application. The study was to also examine the efficacy and safety of the two treat- Subjects were randomly assigned by sealed-envelop ments following one or two applications without the use randomization to receive Sodium Chloride or Permethrin during the treatment period. An equal number of subjects were allocated into each arm of the study. This was an 2. Methods
open-label study; as such, the investigators, site person- nel and the subjects were aware of the product being 2.1. Study Population
The study was approved by The Investigational Review Test product was 1% Sodium Chloride (0.1709 M) Copyright 2013 SciRes. PP
Evaluation of the Efficacy and Safety of 1% Sodium Chloride (LiceFreee Spray) against 1% Permethrin Crème Rinse on Head Lice Infested Individuals spray (LiceFreee Spray®, in 6 ounce bottles; Lot number at Days 8 and 15. The detection of any live lice on a sub- J1821 by Tec Laboratories, Inc. Albany, Oregon), and ject was considered a treatment failure with either prod- reference product was 1% Permethrin Crème Rinse (Nix®, uct used. Numbers of live lice and nits observed in the Insight Pharmaceuticals, LangHorne, PA, in 2 fluid ounce left, middle, and right side of the head were recorded for bottles, 280 mg/fluid ounce; Lot number NX0908—Ex- all time points but the number of nits was estimated only piration 3/2012). The doses used for test and reference products were strictly followed as outlined on product Assessment of other symptoms such as pruritus, ery- thema, presence of secondary infection, and excoriation Subjects had the products applied on Day 1 by inves- was recorded at each visit using a 4-point scale (none 0, tigative site personnel after determination of meeting mild 1, moderate 2, or severe 3). Vital sign measure- study inclusion criteria. The time of application, the ments such as systolic, diastolic blood pressure and pulse weight of the bottle before and after application, the time rate, examined after the subject rested in a seated posi- elapsed until the hair was considered dry (for Sodium tion for at least 5 minutes, and evaluation of existence of Chloride spray), the start and end time of rinsing (for red eyes were performed at each visit. Urine pregnancy test was performed at the Screening Visit (Day 1) only to In the Sodium Chloride spray arm, the product was ensure all females of child-bearing potential were not sprayed on the hair until the hair was completely satu- rated. The hair was then allowed to dry naturally. Effi- cacy evaluation was performed 1 hour after the applica- 2.4. End Points
tion of Sodium Chloride or earlier if the hair was com- The primary measurements were the safety and efficacy pletely dry using a metal comb. The participants were in the reduction of the total number of lice observed on asked to wait 24 hours before returning to their normal the subject’s head and scalp after treatment assessed on hair hygiene. For those in the Permethrin Crème Rinse Day 1, 8 and 15. An evaluation was performed at each treatment group, the hair was washed with baby shampoo subject’s visit to determine whether their eyes were clear (Johnson and Johnson, New Brunswick, NJ) without (value recorded 0) or red (value recorded 1). Additional conditioner and then rinsed with water. The hair was assessments during the study for frequency of pruritus, towel dried. Permethrin Crème Rinse was then applied to erythema, presence of secondary infection, or excoriation saturate the hair, scalp, behind the ears and to the nape of were performed at each subject’s visit using a four point the neck. After 10 minutes of treatment with Permethrin Crème Rinse, the hair was rinsed with warm water and towel dried and efficacy of the treatment was assessed 2.5. Statistical Analysis and Expression of the
using a metal comb. Subjects received treatment at the time they were in the clinic which varied based on ap- pointment time. No nit combs were used during the study. The sample size of 20 subjects per treatment group was a If live lice were observed at the second visit (Day 8), the feasible sample size to provide descriptive statistics for subjects received a second treatment with the assigned the efficacy and safety parameters as no formal calcula- test products following the same procedures mentioned tion of power or sample size was performed in this study. Fisher test and t-test were used when applicable to com- pare the efficacy of 1% Sodium Chloride spray product 2.3. Assessment of Efficacy and Safety
in eliminating head lice to that of Permethrin. The following parameters were calculated: The pro- After the initial application of the products on Day 1, portion of subjects that were 100% free of live lice in evaluation and follow-up visits were performed at day 7 each treatment group immediately post-dosing, and at the and day 14, respectively, with a ±1 day window (Day 8 Day 8 and Day 15 visits and the proportion of subjects and Day 15 visit). Demographic parameters such as date that required retreatment to be 100% free of lice at day of birth, gender, race, ethnicity, size of household, and 15 visit was recorded. For comparison, Fisher test and hair characteristics (length, texture, and curliness) were two sided 95% confidence interval were performed on recorded together with medical history and current medi- the difference in proportion between treatment groups. The numbers of live lice per head before the treatment During examination, hair and scalp were assessed for and after each visit were also counted for the comparison the number of live lice at pre-treatment, immediately between treatments. A p-value < 0.05 was considered after the treatment at Day 1 (and if applicable, on Day 8), Copyright 2013 SciRes. PP
Evaluation of the Efficacy and Safety of 1% Sodium Chloride (LiceFreee Spray) against 1% Permethrin Crème Rinse on Head Lice Infested Individuals 3. Results
3.2. Efficacy Assessment
3.1. Demographic Characteristics of the
Immediately following treatment assessment (Figure 1)
on Day 1, 79.2% Sodium Chloride Spray subjects (16 of 21) and 66.7% Permethrin subjects (14 of 21) were lice Forty-two subjects participated in the study were assigned free (p > 0.05). At Day 8 visit, 25.0% subjects (5 out of equally into each treatment group (Sodium Chloride 20) in Sodium Chloride Spray arm and 75.0% subjects spray or Permethrin). All females of child-bearing poten- (15 out of 20) in Permethrin arm required another course tial had negative pregnancy tests on Day 1 prior to their of treatment (p < 0.05). Of those requiring retreatment at participation in this study. One subject in each treatment Day 8 visit, 3 of 5 Sodium Chloride spray subjects group completed the first treatment and first assessments (60.0%) were successfully treated as compared to 5 of 15 but dropped out of the study prior to Day 8, and twenty Permethrin subjects (33.0%) (p > 0.05). Figure 2 pre-
subjects in each treatment group completed the study. sents the percentage of subjects free of lice at the end of As shown in Table 1, there were no differences in age,
the course of treatment (Day 15 visit), 85.0% of the sub- race, and gender in the two treatment groups. Nearly half jects in Sodium Chloride Spray arm and 45.0% of the of all subjects had average texture to the hair (47.6% in subjects in Permethrin arm (p < 0.05). both treatment groups) but the curliness and length var- The number of live lice presented prior to the initial ied. The number of individuals with long and extra-long treatment was comparable in both treatment groups (21.76 hair was higher in Sodium Chloride spray arm while range 10 to 68 lice and 21.29 range 10 to 60, p > 0.05, curly hair occurred more in Permethrin arm. for Sodium Chloride Spray and Permethrin Crème Rinse, respectively). Immediately after treatment on Day 1, Table 1. Each treatment group’s subject demographic char-
treatment failure subjects treated with Sodium Chloride Spray had 1.95 ± 1.28 lice as compared to 2.95 ± 6.27 in the Permethrin group (p > 0.05). At Day 8, the number of lice in subjects of the Sodium Chloride Spray treatment failure group was 1.40 ± 2.19 as compared to 2.95 ± 2.98 Ethnicity
Figure 1. The percentage of subjects lice free after the 1st
20 95.24 application and 2nd application for individuals needing a
second treatment as assessed at Day 1 and 8 for Sodium
Chloride Spray treatment arm of the study compared to the
Permethrin treatment arm (p < 0.05).
Figure 2. The percentage of subjects lice free at Day 15
(completion of the study) for Sodium Chloride Spray
treatment arm compared to Permethrin treatment arm (p <
8 38.10 0.05).
Copyright 2013 SciRes. PP
Evaluation of the Efficacy and Safety of 1% Sodium Chloride (LiceFreee Spray) against 1% Permethrin Crème Rinse on Head Lice Infested Individuals At Day 15, the number of lice observed in the treat- due to the number of subjects included in the study. One ment failure subjects of the Sodium Chloride Spray group subject (white, Hispanic, 11 year old female with ex- was 0.55 ± 1.5 compared to 5.45 ± 7.91 in the Permethrin tra-long, fine, straight hair), with Sodium Chloride spray, group (p < 0.01). The summary of the efficacy results is reported a headache on Day 4 of the study, for which she presented in Table 2.
self-administered one dose of ibuprofen (Motrin®). This adverse event was the only one reported in the study and 3.3. Extent of Exposure
Sixteen of the twenty-one subjects in the Sodium Chlo- 3.5. Safety Assessment
ride Spray arm received only the first application on day one (all were free of lice on day eight assessment) while No abnormal or significant differences in vital signs were another 6 subjects received a second application on day measured for subjects in this study between the treatment eight. One subject failed to return for the day eight as- groups. During the study, no serious adverse events were sessment. This compares to six subjects receiving one observed. Future studies are needed to fully assess ad- application (subjects were free of lice on day eight as- verse events as the number of subjects in the study was sessment) and another 15 subjects receiving a second application of 1% Permethrin Crème Rinse on day eight. Again one subject failed to return for the day eight as- 4. Discussion
Traditional approaches to treat head lice infestations in- clude using natural oils, nit combing and hair removal 3.4. Adverse Events
have resulted in low effectiveness or are undesirable . As presented in Table 3, the secondary characteristics
Using OTC pediculicidal chemicals remains the most such as pruritus, erythema, secondary infection, and ex- popular method for treating head lice infestations. Recent coriation of the lice infestation from Sodium Chloride studies have shown a dramatic reduction in insecticidal Spray treated group were comparable to the control group. activity because of increased resistance to the current However, the improvement in pruritus in subjects treated insecticides [14,19]. With current pediculicides, it has with Sodium Chloride was consistently greater compared been shown that resistance to popular “old” OTC prod- to Permethrin Crème Rinse (day one 1.14 + 1.1 versus ucts by head lice is genetically regulated [12,20], sug- 0.71 + 0.49; day 15 0.29 + 0.47 versus 0.43 + 0.53 for gesting that the use of these agents may become imprac- Sodium Chloride and Permethrin, respectively) however, tical, and more effective products should be considered these values were not statistically significantly different Table 2. Efficacy results observed for subjects in each treatment group at each treatment day.
Day 1 Post treatment Lice—standard deviation Day 1 Post treatment Lice—95% confidence interval Number subjects with NO Lice post-treatment Number subjects with NO Lice at Day 8 pre-treatment Day 8 Post treatment Lice—standard deviation Day 8 Post treatment Lice—95% confidence interval Day 15 Post treatment Lice—standard deviation Day 15 Post treatment Lice—95% confidence interval Copyright 2013 SciRes. PP
Evaluation of the Efficacy and Safety of 1% Sodium Chloride (LiceFreee Spray) against 1% Permethrin Crème Rinse on Head Lice Infested Individuals Table 3. Subject evaluation values for pruritus, erythema, secondary infection, excoriation, and eyes during each treatment
period of the study.
Visit-1 post treatment
Visit-2 post treatment
1.14 0.71 0.36 0.29 0.43 0.57 0.11 0.17 0.29 0.43 1.10 0.49 0.63 0.49 0.51 0.53 0.33 0.41 0.47 0.53 Erythema
0.14 0.00 0.10 0.00 0.05 0.00 0.00 0.00 0.00 0.00 Infection
0.07 0.00 0.05 0.00 0.05 0.00 0.00 0.00 0.00 0.00 Excoriation
0.14 0.00 0.10 0.00 0.05 0.00 0.00 0.00 0.00 0.00 a: Day 1 pretreatment assessment; b: Day 1 post treatment; c: Day 8 pretreatment; d: Day 8 post treatment; e: Day 8 and 15 post treatment combined assessment for subjects completing study. The effective treatment rate in this study of 1% So- Crème Rinse is important because Permethrin Crème dium Chloride Spray was superior to 1% Permethrin Rinse is to be applied to towel dried hair requiring addi- Crème Rinse immediately after the first application. This tional effort and time on the part of the users, whereas is a very important factor because parents, children, and 1% Sodium Chloride spray can be directly applied to hair infested individuals experience anxiety and stress upon without any preparation providing added convenience observing live lice crawling on their scalp after treatment, and less effort in treatment. One can question the possi- which may lead to unexpected psychological trauma [1, ble interference of moisture on subjects’ hair in this study 21]. The one hour treatment time of Sodium Chloride that may cause the reduction of Permethrin activity but in spray is a feasible length of time for an absence-of-lice another Permethrin study , the product was applied to condition to occur due to the highly effective results ob- damp hair with 97% effectiveness, assessed two weeks served after one application. The study personnel com- post treatment, suggesting that the current poor activity mented regularly on the ease of application and use of of permethrin is most likely because of another reason the Sodium Chloride spray product over the 1% Perme- thrin Crème rise product though this was not evaluated One of the suggested alternatives for the treatment of during the study. The second application of Sodium Chlo- therapy-resistant head lice is the use of prescription prod- ride spray a week later also provides an identical re- ucts . In addition to a greater level of toxicity, the sponse leading to superior results in comparison to the economic burden of prescription products, the waiting reference product. The lower rate of retreatment in the time and cost for physician visits add to the inconven- Sodium Chloride Spray group may also be an indication ience of this treatment option making a simple and inex- that may be the result of the ovicidal capacity of the pensive OTC product a more feasible treatment option. product clinically. The in vivo ovicidal efficacy of So- Another alternative OTC product on the market recently dium Chloride Spray has yet to be determined, however, evaluated for efficacy has its active ingredient dimethi- in vitro data have shown that ovicidal activity of gelled cone [26-29]. The reported mechanism of action of di- 10% Sodium Chloride formulation is greater than that of methicone on lice  is consistent with observations Permethrin and other tested chemicals . The superior reported by Fahmy et al.  in in-vitro studies per- efficacy of Sodium Chloride Spray to 1% Permethrin formed here. The mechanism of action of Sodium Chlo- Copyright 2013 SciRes. PP
Evaluation of the Efficacy and Safety of 1% Sodium Chloride (LiceFreee Spray) against 1% Permethrin Crème Rinse on Head Lice Infested Individuals ride on lice is not fully known but similar rupture of the Miller, “Clinical Observations Related to Head Lice In- gastrointestinal tract in lice is observed with its applica- festation,” Journal of the American Academy of Derma- tology, Vol. 25, No. 2, 1991, pp. 248-251. tion. Desiccation is suggested as the mode of action of Sodium Chloride which explains the one hour exposure to lice for its effects to occur. The ingredients in Sodium  D. Taplin and T. L. Meinking, “Scabies, Lice, and Fungal Infections,” Primary Care, Vol. 16, No. 3, 1989, pp. 551- Chloride spray include Water, 1% Sodium Chloride and Poloxamer 188 (a surface active wetting agent to provide  M. Tebruegge, A. Pantazidou and N. Curtis, “What’s more efficient water and salt contact with the louse) as Bugging You? An Update on the Treatment of Head Lice Infestation,” Archives of Disease in Childhood—Educa- The concentration of Sodium Chloride must be hyper- tion and Practice, Vol. 96, No. 1, 2010, pp. 2-8. tonic to be effective against lice. Therefore, dilution of the active ingredient to hypotonic concentrations nullifies  K. Y. Mumcuoglu, T. A. Meinking, C. N. Burkhart and C. Sodium Chloride’s activity against lice. In addition, So- G. Burkhart, “Head Louse Infestations: The “No Nit” dium Chloride must remain in contact with the louse in Policy and Its Consequences,” International Journal of liquid form for an extensive period of time to be effective. Dermatolog, Vol. 45, No. 8, 2006, pp. 891-896. doi:10.1111/j.1365-4632.2006.02827.x The Poloxamer 188 is included in the product to facilitate Sodium Chlorides extended residence on the louse.  CDC, “Parasites-Lice-Head Lice Diagnosis,” 2011. http://www.cdc.gov/parasites/lice/head/diagnosis.html The present study demonstrates that 1% Sodium Chlo- ride Spray is a simple application, and supplies an excel-  C. N. Burkhart and C. G. Burkhart, “Fomite Transmission lent medical alternative to the current recommended in Head Lice,” Journal of the American Academy of Dermatology, Vol. 56, No. 6, 2007, pp. 1044-1047. treatment for head lice to 1% Permethrin Crème Rinse. With the increase in the resistance of head lice to Perme-  M. Takano-Lee, J. D. Edman, B. A. Mullens and J. M. thrin developing across the country, 1% Sodium Chloride Clark, “Transmission Potential of the Human Head Louse, Spray is a great option for the treatment of head lice. The Pediculus capitis (Anoplura: Pediculidae),” International application of either Sodium Chloride Spray or Perme- Journal of Dermatolog, Vol. 44, No. 10, 2005, pp. 811- thrin provides no safety concerns in the population treated. 816. doi:10.1111/j.1365-4632.2005.02418.x The lack of using a metal nit comb during the study was  A. M. Downs, K. A. Stafford, L. P. Hunt, J. C. Raven- designed to provide a direct assessment of the two prod- scroft and G. C. Coles, “Widespread Insecticide Resis- ucts. The study also provides an indirect assessment of tance in Head Lice to the Over-the-Counter Pediculocides ovicidal activity due to the day eight and fifteen post- in England, and the Emergence of Carbaryl Resistance,” treatment head lice evaluations which showed minimal British Journal of Dermatology, Vol. 146, No. 1, 2002, pp. 88-93. doi:10.1046/j.1365-2133.2002.04473.x reinfestation that would occur if nits survived the initial treatment. Use of a metal nit comb in therapy is likely to  T. L. Meinking, M. Vicaria, D. H. Eyerdam, M. E. Villar, S. Reyna and G. Suarez, “Efficacy of a Reduced Applica- provide greater efficacy during therapy, but the extent of tion Time of Ovide Lotion (0.5% Malathion) Compared the improvement will need to be evaluated in the future. to Nix Creme Rinse (1% Permethrin) for the Treatment of Head Lice,” Pediatric Dermatology, Vol. 21, No. 6, 2004, 5. Acknowledgements
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Role of the USA in shortage of food and medicine in CubaFor over 30 years an embargo by the USA has restricted Cuba’s ability to purchase foods and medicines. In 1992, theUSA enacted the Cuban Democracy Act (CDA), which “exempted” the sale of medicines from the embargo. However,the implementation of the CDA’s requirements and the intensification of the embargo as a result of the passage o