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

NCT05862701 | Completed Phase 1

• 1 other identifier: CMH Abbottabad Dermatology
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Scabies

Keywords

scabies; permethrin; ointment; therapeutics

Outcome Measures

Primary Outcomes (3)

• Symptomatic Impovement

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

  4 weeks

• No new lesions formation

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

  4 weeks

• Absence of Pruritus

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

  4 weeks

Study Arms (2)

Permethrin

ACTIVE COMPARATOR

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

Sulfur

ACTIVE COMPARATOR

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

Drug: Sulphur

Interventions

Permethrin DRUG

5% permethrin cream

Also known as: Lotrix

Permethrin

Sulphur DRUG

10% Sulfur ointment

Also known as: Scabion

Sulfur

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or above
• diagnosis with scabies mites

You may not qualify if:

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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

CMH Abbottabad

Abbottābād, Khyber Pakhtunkhawa, 22010, Pakistan

Location

MeSH Terms

Conditions

Scabies

Interventions

Permethrin; Sulfur

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes; Chalcogens; Elements; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 17, 2023
• Study Start: March 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

PA (1)