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

Scabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862701
• Other study ID #: CMH Abbottabad Dermatology
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: Combined Military Hospital Abbottabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• Permethrin
5% permethrin cream
• Sulphur
10% Sulfur ointment

Locations

Country	Name	City	State
Pakistan	CMH Abbottabad	Abbottabad	Khyber Pakhtunkhawa

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic Impovement	Efficacy was assessed by clinical improvement of previous lesionss assessed by visual analogue scale	4 weeks
Primary	No new lesions formation	Efficacy was assessed by absence of new skin lesions assessed by visual analogue scale	4 weeks
Primary	Absence of Pruritus	Efficacy was assessed by absence of Pruritus assessed by visual analogue scale	4 weeks