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CompletedNCT05862701Updated May 17, 2023

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

A Phase 1 interventional study of Permethrin and Sulphur in Scabies, sponsored by Combined Military Hospital Abbottabad. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-05-17.

Sponsored by Combined Military Hospital Abbottabad · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2022, registered Mar 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Scabies

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Keywords

  • scabies
  • permethrin
  • ointment
  • therapeutics
03

In context

Scabies

51 studies on the registry are indexed under Scabies; 10 are open to participants now.

This study's enrollment of 60 is below the median of 183 across 41 interventional studies indexed under Scabies.

Browse Scabies studies →

Lead sponsor

Combined Military Hospital Abbottabad is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • aged 18 years or above
  • diagnosis with scabies mites

Exclusion criteria

Exclusion Criteria:

  • history of allergy to any drug
  • pregnancy
  • lactation
  • history of severe systemic disorders
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Permethrin

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

    Drug: Permethrin

  • Active comparator
    Sulfur

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

    Drug: Sulphur

Interventions

  • 5% permethrin cream

    Also known as: Lotrix

  • DrugSulphur

    10% Sulfur ointment

    Also known as: Scabion

06

What researchers measure

Primary outcomes

  1. Symptomatic Impovement

    Efficacy was assessed by clinical improvement of previous lesionss assessed by visual analogue scale

    Time frame: 4 weeks

  2. No new lesions formation

    Efficacy was assessed by absence of new skin lesions assessed by visual analogue scale

    Time frame: 4 weeks

  3. Absence of Pruritus

    Efficacy was assessed by absence of Pruritus assessed by visual analogue scale

    Time frame: 4 weeks

07

Study locations

1 site
  • CMH Abbottabad
    Abbottābād, Khyber Pakhtunkhawa 22010, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05862701
Lead sponsor
Combined Military Hospital Abbottabad
Responsible party
Dr Aleena Nasir (Principal Investigator, Combined Military Hospital Abbottabad) — Principal investigator
First posted
May 17, 2023
Start date
Mar 1, 2022
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
May 17, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Permethrin

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