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Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies

Primary Purpose

Scabies

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Permethrin
Sulphur
Sponsored by
Combined Military Hospital Abbottabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scabies focused on measuring scabies, permethrin, ointment, therapeutics

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: aged 18 years or above diagnosis with scabies mites Exclusion Criteria: history of allergy to any drug pregnancy lactation history of severe systemic disorders

Sites / Locations

  • CMH Abbottabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Permethrin

Sulfur

Arm Description

Group A treated with application of topical 5% permethrin cream twice with one week interval. Follow-up at 1, 2 and 4 weeks

Group B treated with 10% sulfur ointment for two or three weeks. Follow-up at 1, 2 and 4 weeks

Outcomes

Primary Outcome Measures

Symptomatic Impovement
Efficacy was assessed by clinical improvement of previous lesionss assessed by visual analogue scale
No new lesions formation
Efficacy was assessed by absence of new skin lesions assessed by visual analogue scale
Absence of Pruritus
Efficacy was assessed by absence of Pruritus assessed by visual analogue scale

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
May 8, 2023
Sponsor
Combined Military Hospital Abbottabad
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1. Study Identification

Unique Protocol Identification Number
NCT05862701
Brief Title
Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies
Official Title
Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sarcoptes scabiei is responsible for a skin infection called scabies. Permethrin is most widely used anti-scabicidel drug and is taken as drug of choice because of its efficacy, safety and patient's compliance. Sulfur 6-33%, as cream, ointment or lotion, is recommended by the European guidelines as an effective alternative treatment and is among the oldest treatments used for scabies. It is recommended to be applied for 3 consecutive days. Both permethrin and sulfur have been shown in previous studies to be superior to other anti-scabietic drugs in terms of efficacy. Two studies showed that permethrin was more efficacious than sulfur, whereas a single study showed otherwise. Therefore, only a few studies are available to find a direct comparison of the efficacy of topical 5% permethrin and topical 10% sulfur in the treatment of scabies and none of them have been carried out in Pakistan. The objective of the study is to compare the efficacy of topical 5% permethrin cream and sulfur 10% ointment in the treatment of scabies.
Detailed Description
The mite named as Sarcoptes scabiei is responsible for a skin infection called scabies. This parasite is a tiny mite that is commonly not visible without a microscope and is present at stratum corneum level in the skin. It burrows in the patient's skin and causes this contagious infection. Permethrin is an insecticide that kills the mites and permethrin 5% cream is among the commonly used drugs for scabies. It is most widely used and taken as drug of choice because of its efficacy, safety and patient's compliance. European guidelines for the management of scabies recommend 5% permethrin cream to be applied from head to toe for 8-12 hours before washing it off and treatment to be repeated after 7 to 14 days. Sulfur 6-33%, as cream, ointment or lotion, is recommended by the European guidelines as an effective alternative treatment and is among the oldest treatments used for scabies. It is recommended to be applied for 3 consecutive days. Topical Sulfur 5-10% ointment (precipitated sulfur) is among the safe and cost effective treatment options for scabies. The toxicity of sulfur ointment is low and therefore can be used in pregnancy and in children. Efficacy ratio although not very clear from previous data now shows that it cures scabies especially the type called Norwegian scabies. It is recommended to be applied on whole body for 3 successive days. A lot of therapeutic options have been used to treat scabies but still there is a need to study those drugs for their efficacy and duration of treatment to eradicate the scabies completely from the patients and their environment. In a study done in 1994, when the use of permethrin was not very common, there were reports of killing the mites within one hour in vitro but in year 2000, it was reported that 35% mites were still alive even after 3 hours. Both permethrin and sulfur have been shown in previous studies to be superior to other anti-scabietic drugs in terms of efficacy. Two studies showed that permethrin was more efficacious than sulfur, whereas a single study showed otherwise. Therefore, only a few studies are available to find a direct comparison of the efficacy of topical 5% permethrin and topical 10% sulfur in the treatment of scabies and none of them have been carried out in Pakistan. The objective of the study was to compare the efficacy of topical 5% permethrin cream and sulfur 10% ointment in the treatment of scabies. The hypothesis of the study was that there is a significant difference in efficacies of 5% permethrin cream and 10% sulfur ointment in the treatment of scabies. The study will help the dermatologists to develop better drug treatment strategies for their patients, and will also assist in curbing the spread of this disease to the community hence reducing its burden.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scabies
Keywords
scabies, permethrin, ointment, therapeutics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Permethrin
Arm Type
Active Comparator
Arm Description
Group A treated with application of topical 5% permethrin cream twice with one week interval. Follow-up at 1, 2 and 4 weeks
Arm Title
Sulfur
Arm Type
Active Comparator
Arm Description
Group B treated with 10% sulfur ointment for two or three weeks. Follow-up at 1, 2 and 4 weeks
Intervention Type
Drug
Intervention Name(s)
Permethrin
Other Intervention Name(s)
Lotrix
Intervention Description
5% permethrin cream
Intervention Type
Drug
Intervention Name(s)
Sulphur
Other Intervention Name(s)
Scabion
Intervention Description
10% Sulfur ointment
Primary Outcome Measure Information:
Title
Symptomatic Impovement
Description
Efficacy was assessed by clinical improvement of previous lesionss assessed by visual analogue scale
Time Frame
4 weeks
Title
No new lesions formation
Description
Efficacy was assessed by absence of new skin lesions assessed by visual analogue scale
Time Frame
4 weeks
Title
Absence of Pruritus
Description
Efficacy was assessed by absence of Pruritus assessed by visual analogue scale
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18 years or above diagnosis with scabies mites Exclusion Criteria: history of allergy to any drug pregnancy lactation history of severe systemic disorders
Facility Information:
Facility Name
CMH Abbottabad
City
Abbottābād
State/Province
Khyber Pakhtunkhawa
ZIP/Postal Code
22010
Country
Pakistan

12. IPD Sharing Statement

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Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies

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