A Phase 1 interventional study of Ivermectin Tablets and Permethrin Cream in Scabies, sponsored by Combined Military Hospital Abbottabad. Completed at 1 site in Pakistan. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Combined Military Hospital Abbottabad · Phase 1, Interventional, and Treatment
Globally, Scabies infects 300m people each year. In children of developing countries, its prevalence is expected to be about 5 to 10%.In Pakistan, Scabies accounts for 38% of dermatological diseases. Males were more prone to infestation than females, and early school-aged children were the most vulnerable. It was more widespread in urban than in rural areas. A distinct seasonal pattern emerged, with the biggest infestation occurring in the winter and the lowest in the summer. Scabies risk factors estimated 89% of the variation in its prevalence.
The classic scabies symptoms include an erythematous papular eruption, burrows, and intense itching. It is usually transmitted by prolonged skin-skin contact. Predilection sites are fingers, axilla, elbows, waist, belly, groin, genital area, etc. Classic scabies can be diagnosed by proper taking history and clinical symptoms. Some of the clinical variations of scabies are Crusted, nodular, and bullous. On examination under a microscope of scrapings collected from skin lesions, finding the mites, eggs, confirms the infestation of scabies .
Topical permethrin and oral ivermectin are the medications of choice for scabies mite elimination. Topical Permethrin 5% applied for 9-14 hours for adults than for children only 8-9 hours. Permethrin 5% only single dose is enough but the second dose can be applied after an interval of 2 weeks if the etiology is still there. Ivermectin is now used to treat scabies, with an effective dosage of 150 to 200 μg/kg given once or may give twice after interval of two weeks. The positives include a single dosage and improved compliance in resistant infestations and situations where head-to-toe topical administration is logistically problematic, such as huge outbreaks or mentally impaired individuals. Fever, arthralgia, myalgia, dizziness, headache, hypotension, tachycardia, and lymphadenopathy have all been reported as adverse effects. There have also been reports of a prolonged prothrombin time, a transient EKG, and variations in liver enzymes.
The study's implications are to analyze the safety and efficacy of these two drugs in order to better treat patients with evidence-based management and rule out any potential adverse effects.
A randomized controlled trial study (single-blind) was done In the Dermatology Unit of the CMH, Abbottabad from June to November 2021 after Ethical Review Board approval, the 100 patients aged 5-80 years after informed consent were enrolled using a technique of non-probability consecutive sampling. The sample size for two proportions was determined using the WHO sample size calculator, with a threshold of significance of 5%. The anticipated population proportion P1 was 80%, while the anticipated population proportion P2 was 46.6% 12. The sample size was calculated to be 100.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 100 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →Combined Military Hospital Abbottabad is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A received Permethrin 5% twice with a one-week interval, whereas Group B received a single dose of oral ivermectin 200 mcg per kg.
Drug: Permethrin Cream
Group A received Permethrin 5% twice with a one-week interval, whereas Group B received a single dose of oral ivermectin 200 mcg per kg
Drug: Ivermectin Tablets
Group B received a single dose of oral ivermectin 200 mcg per kg
Group A received Permethrin 5% twice with a one-week interval.
Complete clearance (outcome assessment at 7 and 14 days post initiation of treatment)
For randomization, the final recruited 100 participants (57 females and 43 men; mean+SD age 35.28+18.51 years, range 5 to 80), randomly assigned to one of two groups i.e. Group A received Permethrin 5% twice with a one-week interval, whereas Group B received a single dose of oral ivermectin 200 mcg per kg. They were instructed not to take any antipruritic or topical medicine. The recruited patients were evaluated and assessed clinically at 2-4-week intervals after treatment by the experienced practitioners who were blinded to the treatment received, in accordance with the criteria described while recruiting the patients.
Time frame: 2 weeks
ADVERSE EFECTS OF DRUGS
Skin itching, swelling, and erythema can happen with scabies patients and may exacerbate following permethrin therapy, Mild stinging or burning might occur as a result of the absorption of dead parasite proteins .
Time frame: 2 weeks
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ivermectin · Permethrin
Combined Military Hospital Abbottabad