ScabiesPhase 4NCT07822672
Sulfur 7% Cream Compared With Permethrin 5% Cream for Treating Scabies in Adults
A Phase 4 study testing Sulfur 7% cream and Permethrin 5% cream in people with Scabies, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scabies
- What is being tested?
- Sulfur 7% cream and Permethrin 5% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cure, Sleep and Treatment Satisfaction With Topical Sulfur 7% Versus Permethrin 5% in Scabies: A Randomized Open-Label Trial
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.
Read the detailed description
Scabies is a highly pruritic skin infestation caused by Sarcoptes scabiei that remains endemic in many resource-limited settings. Permethrin 5% cream is recommended as first-line topical therapy in most international guidelines, but sulfur-based preparations remain widely used because of their low cost and long safety record, particularly in settings where permethrin is expensive or unavailable. Head-to-head comparative data between these two agents, especially data incorporating patient-centered outcomes such as sleep and treatment satisfaction, are limited.
This was a randomized, open-label trial conducted at Can Tho Dermatology Hospital, Can Tho City, Vietnam, enrolling 90 adults aged 18 years or older with a clinical diagnosis of ordinary (non-crusted) scabies, established using the 2020 International Alliance for the Control of Scabies (IACS) consensus criteria. Participants were randomly allocated in a 1:1 ratio to one of two treatment arms. In the sulfur arm, sulfur 7% cream was applied from the neck to the soles each evening, left on for 8-14 hours, and washed off, for three consecutive days. In the permethrin arm, permethrin 5% cream was applied in the same manner as a single overnight application, repeated once after seven days. Both groups received standardized instructions on decontamination of clothing, bedding and towels, and household contacts were offered the same regimen.
Participants were evaluated at baseline, week 2, and week 4. The primary outcome was complete cure, defined according to the 2017 European guideline as resolution of pruritus with no active or new lesions on examination. Secondary outcomes included pruritus severity (verbal rating scale), sleep quality and insomnia symptoms (Athens Insomnia Scale), treatment satisfaction (9-item Treatment Satisfaction Questionnaire for Medication), adverse events, and direct treatment cost. Associations between improvement in itching and improvement in sleep were also examined. Because outcome data were not normally distributed, between-group and within-group comparisons used non-parametric methods (Mann-Whitney U, Wilcoxon signed-rank, chi-square or Fisher's exact test, and Spearman rank correlation).
- Conditions
- Scabies
- Being tested
- Sulfur 7% cream, Permethrin 5% cream
- Keywords
- Scabies, sulfur, pruritus, sleep, treatment satisfaction, permethrin, randomized controlled trial
- Medical subject headings
- Scabies, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfur 7% creamDrug
Applied from neck to soles once each evening, left on for 8-14 hours then washed off, for 3 consecutive days.
Permethrin 5% creamDrug
Applied from neck to soles as a single overnight application (8-14 hours), repeated once after 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: 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% Receives: Drug: Permethrin 5% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure rate at week 2
Proportion of participants achieving complete cure using the same definition as above, assessed at the earlier time point.
Measured: 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.
Measured: Week 4 after treatment initiation
Secondary outcomes (7)
Change in pruritus severity
Change in itching intensity measured by a verbal rating scale (0-4).
Measured: Baseline, week 2, week 4
Change in insomnia symptoms (Athens Insomnia Scale)
Change in sleep disturbance measured by the Athens Insomnia Scale (AIS, 8 items, range 0-24; higher scores indicate worse insomnia).
Measured: Baseline, week 2
Insomnia prevalence
Proportion of participants meeting the AIS cutoff for clinically significant insomnia.
Measured: Baseline, week 2
Treatment satisfaction
Treatment satisfaction measured by the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9), scored across three domains (effectiveness, convenience, global satisfaction; each 0-100, higher scores indicating greater satisfaction).
Measured: Week 4
Incidence of treatment-related adverse events
Proportion of participants experiencing adverse events attributable to study cream (e.g., skin burning, irritation, contact dermatitis).
Measured: Through week 4
Direct treatment cost
Direct cost of the treatment course per participant, converted to US dollars.
Measured: Week 4
Correlation between itch reduction and sleep improvement
Spearman correlation between reduction in pruritus score and improvement in AIS score from baseline to week 2.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Jun 2024
- Primary completion1 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tran Gia Hung, Can Tho University of Medicine and Pharmacy
- Investigators
- Tran Gia Hung, PhD, Principal investigator, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822672
- Sponsor's protocol ID
- 26.041.HV/PCT-HDDD-DC
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.