Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
Primary Purpose
Scabies
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Ivermectin Tablets
Permethrin Cream
Sponsored by
About this trial
This is an interventional treatment trial for Scabies focused on measuring Permethrin 5%, scabies, ivermectin
Eligibility Criteria
Inclusion Criteria:
- More than 2 years
- More than 15kg of body weight
- attended the Dermatology department
Exclusion Criteria:
- Patients under the age of two years
- pregnant
- breastfeeding women
- those with a background of seizures, severe symptoms of systemic illnesses,
- immunosuppression diseases,
- Norwegian scabies
- those who had taken any topical or systemic acaricide medication for one month before the trial
Sites / Locations
- Combined military hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A(permethrin topical)
Group B oral ivermectin
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 .
Full Information
NCT ID
NCT05362513
First Posted
April 21, 2022
Last Updated
April 30, 2022
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05362513
Brief Title
Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
Official Title
Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scabies
Keywords
Permethrin 5%, scabies, ivermectin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A(permethrin topical)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B oral ivermectin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ivermectin Tablets
Intervention Description
Group B received a single dose of oral ivermectin 200 mcg per kg
Intervention Type
Drug
Intervention Name(s)
Permethrin Cream
Intervention Description
Group A received Permethrin 5% twice with a one-week interval.
Primary Outcome Measure Information:
Title
Complete clearance (outcome assessment at 7 and 14 days post initiation of treatment)
Description
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
Secondary Outcome Measure Information:
Title
ADVERSE EFECTS OF DRUGS
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 2 years
More than 15kg of body weight
attended the Dermatology department
Exclusion Criteria:
Patients under the age of two years
pregnant
breastfeeding women
those with a background of seizures, severe symptoms of systemic illnesses,
immunosuppression diseases,
Norwegian scabies
those who had taken any topical or systemic acaricide medication for one month before the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naheed Khan, MBBS
Organizational Affiliation
Cpsp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Combined military hospital
City
Abbottābād
State/Province
Kpk
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24791346
Citation
Ranjkesh MR, Naghili B, Goldust M, Rezaee E. The efficacy of permethrin 5% vs. oral ivermectin for the treatment of scabies. Ann Parasitol. 2013;59(4):189-94.
Results Reference
background
Learn more about this trial
Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
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