INTRODUCTION:

Scabies is parasitic infestation resulted from the Sarcoptes scabiei mite.It is transmitted from patients to others by close contact with infested skin, or shared clothing, bedding. The main complaint is nocturnal itching, rash in whole body but concentrated among fingers, wrist, hands, and umbilicus, in addition to scratch mark on the skin⁽¹⁾.

Scabies is diagnosed clinically, and can be confirmed by microscopic examination to detect scabies mites, or eggs, or feces. Scabies can be prevented when patients' contacts protect themselves by simple measures like hand washing, bed sheets and clothes decontamination by washing or hot laundry and disinfectants during treatment of infested patients and 6 weeks after treatment⁽²⁾. Treatment of contacts is necessary even if they have no symptoms to prevent development of infestation in subclinical period, in addition to main cause which is decrease the chance of scabies infestation. Scabies can be treated easily if patients follow the doctor instructions about dose and drug application⁽³⁾.

Many people had higher risk of infestation who are children, old age, immune compromised, prisoners and those lived in overcrowded living places like displaced poor population (4). Internally displaced population are exposed to greater risk of diseases specifically infections and death. Internally displaced population can exhaust health systems in that place because they had different acute and chronic illnesses (5).

Treatment:

For successful treatment and good outcome, patients should take a warm bath with soap, then dry their body and apply sufficient treatment from chin down but in infants should apply treatment from head down. Skin folds should be treated well. In young children, hands should be covered to prevent ingestion of drugs applied. Treatment repeated after one week to kill newly hatched mites. Decontamination is necessary applied with treatment by washing clothes, bedding, towels, and furniture⁽⁶⁾.

Treated patients should be followed for a period of time ranged from one week up to one month. Outcome during follow up either response to treatment or failure or re-infection⁽⁷⁾ with or without side effect of treatment. Side effect might it ching that usually persists for about one to two weeks after successful treatment but it should be evaluated if prolonged. Causes of persistent itching include cutaneous irritation, allergic contact dermatitis to medications, post-scabetic eczema or may be due to treatment failure. The treatment of side effects include antihistamines, corticosteroids (0.5mg/kg), and emollients⁽⁶⁾

Scabies complications should be treated, these complications may be secondary bacterial infections as Streptococcus pyogenes (Group A) or Staphylococcus aureus⁽⁸⁾. Bacteria may lead to fatal bloodstream, or glomerulonephritis⁽⁹⁾, then renal failure⁽¹⁰⁾.

Treatment regimen:

Scabies can be treated mainly by topical preparations or by systemic treatment:

A. Topical treatment

as lotions, cream, or ointment are applied from neck down, topical treatment includes:

1. Crotamiton:

Topical application cream 10% used for 2 consecutive nights or once overnight or daily for 5 days⁽¹¹⁾. Crotamiton safety isn't proved in newborns and infants. Studies found that crotamiton is less effective than permethrin. It's side effects include conjunctivitis and skin irritation also it had high resistance⁽¹²⁾.

2. Permethrin:

Topical application 2.5%-5% can be applied once⁽¹³⁾ or twice⁽¹⁴⁾ or for two consecutive nights and repeated after two weeks⁽¹⁵⁾. It is effective treatment more than lindane and crotamitone, safe for new born and less toxic than lindane⁽¹⁶⁾, but permethrine resistance was reported⁽¹⁷⁾. It's side effect include skin irritation and burn.⁽⁷⁾

3. Sulfur:

Topical preparation (5% or 10%). It's applied for 3 consecutive nights then for other 3 consecutive nights or can be applied for seven consecutive nights⁽¹⁸⁾. Previously it applied twice a day morning and evening then repeated after ten days⁽¹⁹⁾. It's side effect include skin irritation⁽⁷⁾.

4. Benzyl benzoate:

Topical drug available with 10% for children, 25% for adult applied overnight once⁽²⁰⁾, or twice, each application for 12 hours⁽²¹⁾, or for five consecutive days applications⁽⁷⁾. It cause irritation as contact dermatitis, to avoid side effect can use analgesics and antihistamines⁽²⁰⁾.

5. Decamethrin:

o.o2% applied daily for 2 days and repeated after 1 week⁽²²⁾.

6. Lindane:

Topical treatment 1%, or 0.3% ⁽¹⁸⁾, it applied once⁽²³⁾ or twice^(23,14) to seven⁽¹⁸⁾ applications. Lindane is banned in many countries because it's dangerous side effect as death⁽¹⁶⁾.

7. Synergized natural pyrethrins:

0.16% topical treatment of "pyrethrins synergized and pyperonil butoxide" applied on 2 or 3 consecutive days repeated after 2 weeks^(7,15).

B. Systemic treatment:

Ivermectin used orally with a dose of 100-200 μg/kg body weight^(20,21). Single dose is used. It is effective treatment as benzyl benzoate, permethrin, and lindane)⁽²⁴⁾. Resistance to ivermectin has been recorded among cases with scabies⁽¹⁷⁾

OBJECTIVES:

To compare the effectiveness of single topical scabies treatment with combination, and the association between family size and treatment outcome.

PATIENTS AND METHOD:

Ethical consideration: Ethical approval was obtained from ethic committee in Tikrit Medical College before starting in the study, then permission was taken from each participant in the study after explanation of study objectives, treatment modalities and possible side effects.

The study is comparative clinical trial study conducted in Tikrit city-Iraq from first of January 2016 to the end of December 2017. The sample is cluster sample include (7) camps of internally displaced population. (195) internally displaced patients with scabies chosen randomly from each camp from both sexes. Patients were classified to (7) groups. Researcher was applied different modalities of treatment used for first 6 groups and placebo for control (7^th group) as shown in table below. The data collected and drugs prescribed to patients with instruction about drug application, and other measures that increase successfulness of treatment as treatment of contacts with same treatment modality of their patients, and decontamination of clothes, bed clothes, blankets by washing, leave it for 3days away, and ironing if available. Diagnoses and follow up were done clinically with no laboratory investigation. Patients were followed weekly by researcher to assess patient's condition, if they still had scabies criteria after 4 weeks of treatment, the researcher deals with them as treatment failure. Itching treated by oral antihistamine, or by short course of topical or oral steroids in severe cases.

Inclusion criteria:

persons with scabies but they didn't receive anti scabies treatment previously. Patients were more than 18 years old who voluntary agreed to participate in the study and they had typical scabietic rash, classical burrows, with nocturnal itching and family history of scabies.

Exclusion criteria:

It included age less than 18 years, pregnant, lactating women, allergic to studied drugs, patients with sever illnesses as renal or liver diseases, psychiatric disorders, immune compromised, those with chronic infectious diseases and patients who lost during follow up period but they replaced by others patients to obtain equal number in each group.

The patients were evaluated clinically after 1 week of treatment, if there was no improvement repeated same treatment modality. Patients were examined weekly to assess improvement and drug side effects. The follow-up was continued for 4 weeks, after that, participants were may be cured, cured with drug side effect, treatment failure. Participants with treatment failure treated with combination modalities and followed for other 4weeks and evaluated in same previous method. The participants with drug side effects also treated with antihistamine, corticosteroid, and emollients then re assessed for another one month to assure from cure. Cured participants mean who didn't have new skin lesions and other scabies criteria.

Data presented by simple tables and figures then statistically analyzed and chi square, relative risk (risk ratio-benefit rate), attributable risk (risk reduction), and odd ratio were calculated. Significance are tested at confidence interval 95% (P-value 0.05).

Table 1: Distribution of study sample according to gender, age, and site of lesions.

Distribution according to:	Group1 (30)	Group2 (30)	Group3 (30)	Group4 (30)	Group5 (30)	Group6 (30)	Group7 (15)	Total (195)
Gender
Male	17 (56.7%)	17 (56.7%)	15 (50%)	18 (60%)	14 (46.7%)	18 (60%)	8 (53.3%)	107 (54.9%)
Female	13 (43.3%)	13 (43.3%)	15 (50%)	12 (40%)	16 (53.3%)	12 (40%)	7 (46.7%)	88 (45.1%)
Age
18-	6 (20%)	2 (6.7%)	4 (13.3%)	2 (6.7%)	5 (16.7%)	6 (20%)	3 (20%)	28 (14.4%)
25-	7 (23.3%)	10 (33.3%)	9 (30%)	7 (23.3%)	6 (20%)	5 (16.7%)	6 (40%)	50 (25.6%)
35-	6 (20%)	8 (26.7%)	8 (26.7%)	9 (30%)	7 (23.3%)	6 (20%)	4 (26.7%)	48 (24.6%)
45-	5 (16.7%)	6 (20%)	4 (13.3%)	9 (30%)	4 (13.3%)	7 (23.3%)	2 (13.3%)	37 (19%)
55-	4 (13.3%)	3 (10%)	4 (13.3%)	3 (10%)	5 (16.7%)	4 (13.3%)	0 (0%)	23 (11.8%)
<65	2 (6.7%)	1 (3.3%)	1 (3.3%)	0 (0%)	3 (10%)	2 (6.7%)	0 (0%)	9 (4.6%)
Main lesion distribution
Pubic area	7 (23.3%)	2 (6.7%)	3 (10%)	5 (16.7%)	6 (20%)	4 (13.3%)	4 (26.7%)	31 (15.9%)
Abdomen	8 (26.7%)	6 (20%)	8 (26.6%)	9 (30%)	5 (16.7%)	7 (23.3%)	5 (33.3%)	48 (24.6%)
Wrist	5 (16.7%)	6 (20%)	3 (10%)	4 (13.3%)	3 (10%)	3 (10%)	2 (13.3%)	26 (13.3%)
Cubital area	3 (10%)	5 (16.7%)	2 (6.7%)	1 (3.3%)	4 (13.3%)	2 (6.7%)	1 (6.7%)	18 (9.2%)
Axillary area	1 (3.3%)	4 (13.3%)	5 (16.7%)	5 (16.7%)	4 (13.3%)	3 (10%)	2 (13.3%)	24 (12.3%)
interdigital	4 (13.3%)	3 (10%)	4 (13.3%)	4 (13.3%)	2 (6.7%)	6 (20%)	1 (6.7%)	24 (12.3%)
All body	2 (6.7%)	4 (13.3%)	5 (16.7%)	2 (6.7%)	6 (20%)	5 (16.7%)	0 (0%)	24 (12.3%)

Table 2: Comparison of treatment modalities outcome

Outcome	Group1 (Permethrine10%) (30)	Group2 (crotamiton10%) (30)	Group3 (Sulfur 10%) (30)	Group4 (Permethrine 10% +Sulfur10% (30)	Group5 (crotamiton 10%+ Sulfur10%) (30)	Group6 (crotamiton 10%+ Permethrine 10%) (30)	Group 7 control (placebo) (15)	Total (195)
Cure
1st week	12 (40%)	3 (10%)	9 (30%)	16 (53.3%)	13 (43.4%)	15 (50%)	0 (0%)	68 (34.9%)
2nd week	7 (23.3%)	5 (16.7%)	10 (33.3%)	6 (20%)	9 (30%)	9 (30%)	1 (6.7%)	47 (24.1%)
3rd week	6 (20%)	8 (26.7%)	3 (10%)	4 (13.3%)	3 (10%)	2 (6.7%)	1 (6.7%)	27 (13.8%)
4th week	0 (0%)	7 (23.3%)	2 (6.7%)	2 (6.7%)	1 (3.3%)	1 (3.3%)	2 (13.3%)	15 (7.7%)
Total of cured	25 (83.3%)	23 (76.7%)	24 (80%)	28 (93.3%)	26 (86.7%)	27 (90%)	4 (26.7%)	157 (80.5%)
Failure after 4weeks of treatment	5 (16.7%)	7 (23.3%)	6 (20%)	2 (6.7%)	4 (13.3%)	3 (10%)	11 (73.3%)	38 (19.5%)
Relative Risk (CI=95%)	2.7	2.5	2.6	3.1	2.8	3	----	----
Risk reduction (attributable risk) (CI=95%)	0.56	0.5	0.53	0.66	0.6	0.63	----	-----
Odd ratio (CI=95%)	13.75	12	11	38.5	17.9	24.75	----	----

Table 3: Relation between treatment outcome and family size.

Outcome and family size	Group1 (Permethrine10%) (30)	Group2 (crotamiton10%) (30)		Group3 (Sulfur 10%) (30)			Group4 (Permethrine 10% +Sulfur10%) (30)		Group5 (crotamiton 10% +Sulfur10%) (30)			Group6 (crotamiton 10%+ Permethrine 10%) (30)	Group7 control (Placebo) (15)	Total (195)
Cure
2-4	12 (40%)	8 (26.7%)		10 (33.3%)			8 (26.7%)		8 (26.7%)			6 (20%)	2 (13.3%)	54 (27.7%)
5-7	10 (33.3%)	9 (30%)		8 (26.7%)			14 (46.6%)		9 (30%)			11 (36.8%)	2 (13.3%)	63 (32.3%)
8-10	3 (10%)	4 (13.3%)		6 (20%)			4 (13.3%)		6 (20%)			10 (33.3%)	0 (0%)	33 (16.9%)
10<	0 (0%)	2 (6.7%)		0 (0%)			2 (6.7%)		3 (10%)			0(0%)	0 (0%)	7 (3.6%)
Chi square= 17.03 Degree of freedom= 18 P-value= 0.01 Significant association
Failure after 4 weeks of treatment
2-4			0 (0%)		1 (3.3%)	0 (0%)		0 (0%)		1 (3.3%)	0(0%)		1 (6.7%)	3 (1.5%)
5-7			1 (3.3%)		2 (6.7)	0 (0%)		0 (0%)		0 (0%)	1 (3.3%		4 (26.7%)	8 (4.1%)
8-10			3(10%)		3 (10%)	3 (10%)		0 (0%)		2 (6.7%)	1(3.3%		6 (40%)	18(9.3%)
<10			1(3.3%)		1 (3.3%)	3 (10%)		2 (6.7%)		1 (3.3%)	1(3.3%		0 (0%)	9 (4.6%)

Chi square= 9.4

Degree of freedom= 18

P-value= 0.01

No Significant association

Table 4: Outcome of drugs combination modalities treatment after failure of single drug modalities in 38 patients.

Outcome of 38 patients with treatment failure	Treatment modalities			Total (38)
Outcome of 38 patients with treatment failure	(Permethrine10% + Sulfur10%) (13)	(crotamiton10% + Sulfur10%) (13)	(crotamiton10%+ permethrine10%) (12)	Total (38)
Cure
1st week	7 (53.8%)	6 (46.1%)	7(58.4%)	20(52.6%)
2nd week	2 (15.4%)	4(30.8%)	4 (33.3%)	10(26.3%)
3rd week	4(30.8%)	1(7.7%)	1(8.3%)	6(15.8%)
4th week	0(0%)	2(15.4%)	0(0%)	2(5.3%)
Failure after 4weeks of treatment	0(0%)	0(0%)	0(0%)	0(0%)

Figure 1: Number of patients with side effects of treatment according to gender

Figure 2: Patients complaints (side effects) after treatment

DISCUSSION:

The recent study were achieved when scabies became highly prevalent infectious disease among internally displaced population in Tikrit-Iraq, particularly those lived in camps with variation in response to different treatment modalities. The study applied new approach in scabies treatment by application of combined topical drugs then assesses the effectiveness of them and compares with the effectiveness of single topical treatment. The researcher excluded less than 18 years old patients from study due to ethical considerations, many factors determine the drugs selection and application like the personal preference of physician, availability of drug, cost for the patient and drugs safety than on medical evidence⁽²⁵⁾.

The study found that higher cure rate (93.3%) in group4 ((Permethrine10% +Sulfur10%), the second high cure rate was in group6 (crotamiton10%+Permethrine10%) about (90%). Third cure rate in group5 (crotamiton10%+ Sulfur10%) was (86.7%). Fourth cure rate in group1 (Permethrine10%) was (83.3%). All previous groups with high cure rate in the first week, while these followed by group3 (Sulfur 10%) (80%) with high cure rate in the second week of treatment, and least cured rate was in group2 (crotamiton10%) (76.7%) mostly in the 3^rd week of treatment.

From previous comparison cure rate was higher in combined topical drugs modalities than single topical drug modalities with high rate of case improvement in the first week.

Among combined modalities (permethrine5%+sulfur 10%) was the most effective treatment. The results analyzed statistically and assured that the relative risk rate (benefit rate) of combined topical therapy in scabies treatment was higher than single.

Among single topical treatment, permethrine5% was the most effective single treatment followed by sulfur10% then crotamiton10%. This results agreed by many studies that revealed.

Permethrin5% was more effective (61.1%) after 1 week of treatment, but no patients cured in crotamiton and sulfur group. After 2 weeks of 5%permethrine treatment, cure rate was 100%, while cure rate of crotamiton group at the 2^nd week was (66.7%) compared with (38.9%) cure rate for the 10%sulfur ointment group⁽²⁶⁾. But the study of Pourhasan et al. (2013) reported that, cure rate of permethrin5% cream and cotamiton10% cream were equal after 2 weeks after treatment⁽²⁷⁾. Permethrine is the most effective and first line treatment in scabies because it's miticidal and ovicidal and it is not toxic. Many studies suggest retreatment of scabies patients after 1 week from first dose⁽¹⁶⁾. Limitation in permethrine is it's cost, and permethrine more effective than crotamiton⁽²⁸⁾.

Crotamitone is effective for adult mite, but not kill eggs and larvae. There fore crotamitone is given in 2 applications (1^st and 2^nd week) to eradicate the parasite and for 100% cure. Studies don't recommend crotamiton because of low efficacy and toxicity⁽²⁹⁾ .The oldest and very cheap scabicide is Sulfur ⁽³⁰⁾. Topical sulfur is irritant to skin, odourous, stains clothes and required repeated applications^(31,32)

The results showed that, patients were presented with abdominal lesions in (24.6%) of cases then pubic area in (25.9%). While other studies found that inter digitals lesions was the most common⁽³³⁾.

Family size may affect the frequency of scabies and treatment outcome, the study found that, high cure rate in the first week of treatment with treatment modalities 1,2,3 among smaller family size (2-4) and (5-7) but high failure rate in (8-10) family size. Large family size increase chance of infection spread to healthy family member therefore frequency increased. Also failure rate of treatment increased in large families, to avoid treatment failure all patients contacts should be treated as recommended by the German guideline⁽³⁴⁾.

The study found 38(19.5%) of scabies patients failed to cure after 4 weeks of treatment onset. After that, those patients treated with combined treatment modalities and followed for another 4 weeks, the results showed 100% cure rate after another 4 weeks. Many studies recommended to follow up for 4 weeks (end of mite cycle) to detect new cases among contacts and to assure complete cure from scabies⁽³⁵⁾.

There were other two trials compared permethrin 5% and crotamiton 10%. No statistically significant difference between 2 drugs in complete cure of lesions after 4 weeks (12).

The results showed that side effects of drugs more frequent in groups 3,4,5 (sulfur10%), (permethrine 5% + sulfur10%), (crotamiton10% + sulfur10%) subsequently, the frequent side effect was itching. Side effects may be because of sulfur which includes dryness, irritation, and redness. Other groups were complained from side effects but in less frequency than sulfur contained groups. These findings assure other study that reported the main side effect was skin dryness, especially among patients treated with sulfur (25 d1) The current study showed less side effects in permethrine5% and crotamiton5% groups this agreed with (Amer M, and el-Gharib I) results who didn't found adverse effects with these drugs(12).

CONCLUSION:

1. Patients who treated with combined topical treatment was higher cure rate than single topical treatment.

2. Side effects of treatment more frequent in combined topical treatment particularly in sulfur contained preparation.

3. Treatment failure among (8-10) family members more than other groups.

4. 38 patients with treatment failure were cured 100% after another 4 weeks of combined treatment.

RECOMMENDATION:

1. Perform more clinical trials about new strategies in scabies treatment to get highly effective treatment with less side effects and low cost.

2. Educate people by health education program especially risky groups about control, prevention of scabies transmission, and correct application of treatment.

3. Camps should be followed regularly by health teams to screen and treat health problems particularly infectious diseases.

ACKNOWLEGDMENT:

Great thanks to dr. Nesseer Al-Rawi (Dermatologist) for his help.

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Received on 15.11.2018 Modified on 17.12.2018

Research J. Pharm. and Tech. 2019; 12(3): 1361-1368.

DOI: 10.5958/0974-360X.2019.00229.4

Site name	Sample size (patients)	Type of treatment	Application method
Alam camp1	30	Group1- Permethrine5%^*	once to the whole body below neck and left overnight.
Alam camp2	30	Group2- Crotamiton10%^**	for 2 consecutive nights from neck down
Shaqlawa	30	Group3- Sulfur10%^***	left overnight to the whole body below neck for 3 consecutive nights.
Dream city	30	Group4-permethrine5% + Sulfur10%	Permethrine one application +Sulfur for 3 consecutive night from neck down
Alqadisia	30	Group5-crotamiton10% +Sulfur10%	Crotamiton for 2 consecutive nights+ Sulfur for 3 consecutive night) from neck down
Awja	30	Group6-Permethrine5% +crotamiton10%	Permethrine one application+ for 2 consecutive nights) from neck down
Collection (camp) in Al-Arbaeen	15	Group7 (control) Placebo (vaseline)^****	Vaseline left overnight to the whole body below neck for 3 consecutive nights.
Total	195
The manufacturer, city, and the country of drugs	Permethrine cream 5%---New industrial township-Faridabad-Haryana-India. Crotamiton---Philadelphia Pharmaceuticals-King Abdallah Industrial City- Amman-Jordan Sulfur---Samaraa Drugs Industry-Salahulddin-Iraq **Vasaline--- Samaraa Drugs Industry-Salahulddin-Iraq