Natl. J. Physiol. Pharm. Pharmacol. (2025), Vol. 15(2): 147-152

Research Article

10.5455/NJPPP.2025.v15.i2.6

A prospective observational comparative study of the effectiveness and adverse effects of 5% topical permethrin and oral ivermectin versus 5% topical permethrin alone for the treatment of scabies in a tertiary care hospital

Monika P.*, Nagabushan H. and Shashikumar B. M.

Mandya Institute of Medical Sciences, Mandya, India

*Corresponding Author: P. Monika. Mandya Institute of Medical Sciences, Mandya, India. Email: pmonika0905 [at] gmail.com

Submitted: 23/09/2024 Accepted: 08/01/2025 Published: 28/02/2025

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Abstract

Background: Scabies is a contagious skin conditions that exclusively infect humans and spread through direct skin-to-skin contact.

Aim: This study aimed to compare the effectiveness and adverse effects of 5% topical permethrin and oral ivermectin versus 5% topical permethrin alone for the treatment of scabies.

Methods: This prospective observational comparative study included 150 diagnosed patients with scabies aged > 5 years who were divided into two groups. Group A received 5% permethrin cream and 12-mg of ivermectin, and group B received 5% permethrin cream. The patients were followed up at the first, second, and fourth weeks. The effectiveness of the treatment was assessed according to the reduction in the number and severity of lesions. The severity of itching was assessed by using a Visual Analog Scale (VAS). The adverse effects were also monitored. Statistical analysis was performed using Statistical Package for Social Sciences version 20. Student “t” test, the chi-square test, and the Friedman test were used.

Results: There were 71 males (47.3%) and 79 females (52.6%). Group A exhibited mean and standard deviation (m ± SD) values of 40.3 ± 9.4 and 2.8 ± 3.4 for no. of lesions at baseline and at week 4, respectively. In contrast, Group B had 40.1 ± 10.7 and 2.7 ±3.2 for no. of lesions at these time points. For VAS score, Group A recorded 2.89 ± 0.31 and 0.79 ± 0.68 at baseline and at week 4, while Group B showed 2.81 ± 0.39 and 0.71 ± 0.63 for these respective measures. The groups were compared, and the p value was > 0.05. The incidence of adverse effects was higher in Group A than in Group B.

Conclusion: Both groups showed equal effectiveness in the treatment of scabies.

Keywords: Scabies, Permethrin, Ivermectin, Effectiveness.

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Introduction

Scabies is a contagious skin condition caused by the human itch mite Sarcoptes scabiei var hominis, which exclusively infests humans and spreads through direct skin-to-skin contact (Munge et al., 2021). It is characterized by intense itching and the formation of nodules, papules, and vesicles over the skin (Ibraheem 2019).

Scabies can spread through sharing items such as bedding or clothing with an infested individual or through sexual contact with someone who has scabies. In healthy individuals, scabies infestations are most frequently found on the hands, fingers, finger webs, and wrists. However, in older adults, infants, and those with weakened immune systems, the infestation can be more widespread, affecting areas such as the head, neck, palms, and soles of the feet (Wankhade et al., 2016).

The condition can be effectively treated using topical medications, oral medications, or a combination of both (Sunderkotter et al., 2021). The primary approach for treatment often involves the use of topical insecticidal medications, including permethrin, ivermectin, malathion, lindane, and benzyl benzoate. They induce paralysis, ultimately leading to the death of the mites responsible for scabies (Rosumeck et al., 2018).

Permethrin 5% cream has been proven to be more efficacious than Lindane and has received FDA approval for the treatment of scabies (Zargari et al., 2006). Ivermectin, a broad-spectrum antiparasitic medication, is the primary oral scabicide employed in mass drug administration within populations where scabies are prevalent. FDA approval has been obtained for scabies treatment in several countries (Mueller et al., 2019). The adverse effects of topical permethrin 5% cream are erythema, burning, stinging, and rarely dystonia, including muscle spasms (Sacchidanand et al., 2022).

The aim of the current study was to compare the effectiveness and determine the adverse effects of 5% topical permethrin and oral ivermectin versus 5% topical permethrin alone for the treatment of scabies.

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Materials and Methods

This was a prospective, observational, and comparative study. The Institutional Ethics Committee approved the study, which was conducted from December 2023 to March 2024. A total of 150 patients diagnosed with scabies who visited MIMS Hospital Dermatology Outpatient Department, Mandya district, Karnataka, were randomly allocated to two groups. Group A received 5% topical permethrin and oral ivermectin, whereas group B received 5% topical permethrin.

Inclusion criteria

• Newly diagnosed individuals with scabies, regardless of gender, who are aged above 5 years.

• Patients or their guardians who are willing to provide informed consent or assent to participate in the study.

• History of similar symptoms in contacts or family members.

• The presence of the following clinical criteria:

a. Demonstration of burrows.

b. The presence of typical scabietic lesions.

c. Nocturnal itching

Exclusion criteria

• Patients with other skin conditions that could complicate the diagnosis of scabies.

• Individuals who have undergone scabies treatment in the past 4 weeks.

• Participants or their guardians who do not adhere to the study’s requirements.

• Patients who are unwilling to attend follow-up visits.

• Past-allergic reactions to any medications used in the study.

• Women who are pregnant or breastfeeding.

Study process

Patients who satisfied the inclusion/exclusion criteria were enrolled and randomized into two groups. At the baseline visit, demographic data medical history, concomitant medications, and physical and clinical evaluation were recorded.

Scabies were categorized into four grades based on lesion counts. Grade 0 indicated no lesions, Grade 1 was mild with 10 or fewer lesions, Grade 2 was moderate (11–49 lesions), and Grade 3 was severe (50 lesions). Itching intensity was measured using the visual analog scale (VAS) score. Scores from 0 (no itching) to 10 (severe itching) were categorized as mild (1–3), moderate (4–6), or severe (7–10). Based on earlier comparable studies, the sample size was determined (Dey et al., 2022).

Patients in Group A received a combination of 5% topical permethrin and oral ivermectin (200 mcg/kg). Permethrin cream (5%) was instructed to be applied all over the body, from the neck to the toe, and left for at least 8–12 hours. They were advised to use a warm water bath. Ivermectin was administered once a week total of 2 doses. Patients in Group B received 5% topical permethrin alone.

They were also advised to prevent the spread of the infestation by washing and drying all contaminated clothing and bedding in sunlight. Patients were regularly monitored, with assessments at the first, second, and fourth weeks after starting treatment. The effectiveness of the treatment and any adverse effects were evaluated during follow-up visits. Patients underwent thorough examination during each follow-up visit, and the results were compared with baseline values.

Statistical analysis

The data collected were entered into Microsoft Excel software, and the Statistical Package for Social Sciences IBM trial version 20 was used. Descriptive statistics such as mean and standard deviation for continuous data and percentages for categorical data were used. Inferential statistics “t” test to determine the difference between means of two groups. Chi-square test to determine the association of severity of lesions and severity of pruritis with adverse effects. Friedman test was used to determine repeated measures during follow-up visits. P < 0.05 was considered statistically significant.

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Results

A total of 150 patients included in the study were grouped into two treatment groups. The demographic data and baseline characteristics of the patients were recorded and compiled. (Table 1).

Assessment of lesions

The study compared two treatment groups for scabies lesions over a 4-week period. In group A, there was a notable improvement in lesions from baseline to first week (47.9%), second week (75.2%), and fourth week (93.1%). Similarly, group B showed improvement in lesions from baseline to the first week (47.7%), second week (76.5%), and fourth week (93.3%) (Fig. 1).

The mean number of lesions in group A decreased from 40.3 ± 9.4 at baseline to 2.8 ± 3.4 in the fourth week, with significant improvement within the group (p < 0.05). The mean number of lesions in group B decreased from 40.1 ± 10.7 at baseline to 2.7 ± 3.2 in the fourth week, which also showed statistically significant improvement within the group (p < 0.05) (Table2).

However, when comparing the groups, the p values were 0.12, 0.32, and 0.22 at the first, second, and fourth weeks, respectively, indicating no statistically significant difference. (Table 2).

Assessment of pruritis

The study utilized VAS scores to assess itching levels at baseline and at the first, second, and fourth weeks in the two treatment groups, as depicted in Figure 2. In group A, itching improved over the follow-up period, with values of 24%, 46%, and 72.7%, respectively. Similarly, in group B, itching improved, with values of 20.6%, 42%, and 74.7% at the first, second, and fourth weeks, respectively (Fig. 2).

The m ± SD of itching severity in group A at baseline was 2.81 ± 0.39. Significant improvement was observed within group A, with mean scores decreasing to 2.20 ± 0.8, 1.56 ± 0.62, and 0.79 ± 0.68 at the first, second, and fourth weeks, respectively (p=0.001). In group B, the initial itching severity was recorded as 2.81 ± 0.39 (Table 3). Subsequent assessments showed significant improvement, with mean scores dropping to 2.23 ± 0.81, 1.63 ± 0.54, and 0.71 ± 0.63 at the corresponding time points (p=0.001). However, comparisons between groups A and B indicated no significant differences, with p values of 0.202, 0.321, and 0.744 at the first, second, and fourth weeks, respectively (Table 3).

Comparison of adverse effects

In the present study, Group A experienced more adverse drug reactions than Group B. In Group A, the most common adverse effect was headache, followed by nausea. In Group B, the sensation of burning and skin rash (Table 4).

Table 1. Demographic characteristics of the patients in the two treatment groups.

Fig. 1. Comparative improvement of the lesions in two treatment groups.

Table 2. Effectiveness of treatment between two groups based on no. of lesions.

Fig. 2. Comparative improvement of the pruritus in two treatment groups.

Table 3. Effectiveness of treatment between two groups based on pruritis.

Table 4. Comparison of adverse effects between two groups.

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Discussion

The clinical cure rates were 47.9% and 47.7% in the combination and 5% permethrin groups, respectively, at the end of the first week. By the fourth week, it was 93% in both groups. These findings differed from those of a study by Wankande et al. (Wankhade et al., 2016) in which the clinical cure rate was higher at the first week (86% and 78%) and at the fourth week (96% and 90%), respectively. The p-values from (Dey et al., 2022) were (0.15 at the first week and 0.84 at the fourth week) were similar to our study (0.202 and 0.744), which was not significant.

In our study, topical 5% permethrin showed a 47% clinical cure rate at the end of the first week, contrasting with other studies by Rosumeck et al. (Rosumeck et al., 2018) Chhaiya et al. (Chhaiya et al., 2012) and Usha and Gopalakrishnan Nair (Usha and Gopalakrishnan Nair 2000), where cure rates were 65%, 74.8%, and 97.8%, respectively. Bachewar et al. (2009) observed a 76% improvement with permethrin treatment at the end of the first week, which differs from our findings. However, Das et al. (2006) reported improvement rates of 70% and 90% in the second and fourth weeks, respectively, which are consistent with our results. Maurya et al. (2014) reported cure rates of 83.3% and 93.5% in the first and fourth weeks, respectively. By the fourth week, the values correspond to those in our study.

Meenakshi et al. (2014), Sharma and Singh et al. (2011), and Ranjkesh et al. (2013) reported cure rates of 93.5%, 94.7%, and 96.9% at the end of the fourth week, which supported our findings. They also suggested that two-dose ivermectin is as effective as permethrin. Goldust et al. (2012) found a 92.5% cure rate with permethrin after 2 weeks, which was statistically nonsignificant and consistent with our study.

No major adverse drug reactions were observed. In the combination group, headache was the most common adverse reaction, followed by nausea, diarrhea, and dizziness. In the permethrin group, a transient burning sensation and skin rash were noted. Similar results were obtained in the studies by Dey et al. (2022), Chhaiya et al. (2012), and Al-Azdi (2023).

Limitations

This study has several limitations. First, this study is single-centric with a small sample size, and only two antiscabietic medicines were included. Cost-effectiveness was not assessed. In addition, only a limited number of studies have compared the effectiveness of combination therapy.

Therefore, further research is necessary to compare the effectiveness of various antiscabietic medications using larger sample sizes at multiple sites. By developing awareness campaigns, particularly for high-risk individuals, the general public must be educated about disease transmission, prevention, and management.

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Conclusion

From this study, it can be concluded that topical 5% permethrin is as effective as a combination of oral ivermectin and topical permethrin for reducing lesions and improving pruritis in patients with scabies. The combination group had more adverse effects than the permethrin group.

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Acknowledgment

This work was attributed to the Department of Pharmacology, Department of Dermatology, Venerology and Leprosy, Mandya Institute of Medical Sciences, Mandya, Karnataka, India.

Conflicts of interest

The authors declare no conflicts of interest.

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