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Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05362513
Recruitment Status : Completed
First Posted : May 5, 2022
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Naheed khan, Combined Military Hospital Abbottabad

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.


Condition or disease Intervention/treatment Phase
Scabies Drug: Ivermectin Tablets Drug: Permethrin Cream Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies

Arm Intervention/treatment
Active Comparator: Group A(permethrin topical)
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.

Active Comparator: Group B oral ivermectin
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




Primary Outcome Measures :
  1. Complete clearance (outcome assessment at 7 and 14 days post initiation of treatment) [ Time Frame: 2 weeks ]

    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 :
  1. ADVERSE EFECTS OF DRUGS [ Time Frame: 2 weeks ]
    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 .



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05362513


Locations
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Pakistan
Combined military hospital
Abbottābād, Kpk, Pakistan
Sponsors and Collaborators
Combined Military Hospital Abbottabad
Investigators
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Principal Investigator: Naheed Khan, MBBS Cpsp
Publications:
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Responsible Party: Naheed khan, principal investigator, Combined Military Hospital Abbottabad
ClinicalTrials.gov Identifier: NCT05362513    
Other Study ID Numbers: CMHatd-ETH-23-derm-22
131/CPSP ( Other Identifier: CPSP )
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naheed khan, Combined Military Hospital Abbottabad:
Permethrin 5%
scabies
ivermectin
Additional relevant MeSH terms:
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Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Infections
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Permethrin
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action