NCT07822672

Brief Summary

This study compares two creams used to treat scabies, a common skin condition caused by mites that causes intense itching. Ninety adults with scabies were randomly assigned to receive either sulfur 7% cream or permethrin 5% cream. Sulfur cream was applied once each evening for three nights in a row; permethrin cream was applied once, left on overnight, and repeated after one week. Participants were examined after two weeks and again after four weeks to see whether the scabies had cleared. The study also looked at how quickly itching improved, how much sleep improved, how satisfied participants were with each treatment, how many side effects occurred, and how much each treatment cost. The goal is to help doctors and patients choose between these two widely available, inexpensive treatments based on real-world evidence of how well each one works and how well it is tolerated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

September 6, 2026

Last Update Submit

September 12, 2026

Conditions

Keywords

Scabiessulfurpruritussleeptreatment satisfactionpermethrinrandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Complete cure rate at week 2

    Proportion of participants achieving complete cure using the same definition as above, assessed at the earlier time point.

    Week 2 after treatment initiation

  • Complete cure rate at week 4

    Proportion of participants achieving complete cure, defined per the 2017 European guideline as resolution of pruritus with no active lesions and no new lesions on clinical examination.

    Week 4 after treatment initiation

Secondary Outcomes (7)

  • Change in pruritus severity

    Baseline, week 2, week 4

  • Change in insomnia symptoms (Athens Insomnia Scale)

    Baseline, week 2

  • Insomnia prevalence

    Baseline, week 2

  • Treatment satisfaction

    Week 4

  • Incidence of treatment-related adverse events

    Through week 4

  • +2 more secondary outcomes

Study Arms (2)

Arm 1 (Sulfur 7%)

ACTIVE COMPARATOR

Intervention Type: Drug Intervention Name: Sulfur 7% cream Description: Applied from neck to soles once each evening, left on for 8-14 hours then washed off, for 3 consecutive days. Arm/Group Label: Sulfur 7%

Drug: Sulfur 7% cream

Arm 2 (Permethrin 5%)

ACTIVE COMPARATOR

Intervention Type: Drug Intervention Name: Permethrin 5% cream Description: Applied from neck to soles as a single overnight application (8-14 hours), repeated once after 7 days. Arm/Group Label: Permethrin 5%

Drug: Permethrin 5% cream

Interventions

Applied from neck to soles once each evening, left on for 8-14 hours then washed off, for 3 consecutive days.

Arm 1 (Sulfur 7%)

Applied from neck to soles as a single overnight application (8-14 hours), repeated once after 7 days.

Arm 2 (Permethrin 5%)

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • Clinical diagnosis of ordinary (non-crusted) scabies, established using the 2020 International Alliance for the Control of Scabies (IACS) consensus criteria, category B:
  • B1: burrow identified, or
  • B2: typical lesions at male genitalia, or
  • B3: typical lesions at typical sites plus pruritus and a history of close contact with a person with scabies or itch

You may not qualify if:

  • Known allergy or intolerance to sulfur or permethrin
  • Pregnant or breastfeeding women
  • Hearing, visual, or cognitive impairment preventing reliable self-reporting of symptoms
  • Self-discontinuation of study treatment before completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho Dermatology Hospital

Can Tho, Can Tho City, 900000, Vietnam

Location

MeSH Terms

Conditions

ScabiesPruritus

Interventions

SulfurPermethrin

Condition Hierarchy (Ancestors)

Mite InfestationsEctoparasitic InfestationsSkin Diseases, ParasiticParasitic DiseasesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsPhenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPyrethrinsCyclopentane MonoterpenesMonoterpenesTerpenes

Study Officials

  • Tran Gia Hung, PhD

    Can Tho University of Medicine and Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Dermato-Venereology, Faculty of Medicine

Study Record Dates

First Submitted

September 6, 2026

First Posted

September 16, 2026

Study Start

June 1, 2024

Primary Completion

May 1, 2026

Study Completion

June 1, 2026

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. De-identified summary data may be made available from the corresponding author upon reasonable request, subject to institutional approval.

Locations