A Phase 4 interventional study of Sulfur 7% cream and Permethrin 5% cream in Scabies, sponsored by Can Tho University of Medicine and Pharmacy. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Can Tho University of Medicine and Pharmacy · Phase 4, Interventional, and Treatment
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.
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).
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 90 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
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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
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
Applied from neck to soles once each evening, left on for 8-14 hours then washed off, for 3 consecutive days.
Applied from neck to soles as a single overnight application (8-14 hours), repeated once after 7 days.
Complete cure rate at week 2
Proportion of participants achieving complete cure using the same definition as above, assessed at the earlier time point.
Time frame: 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.
Time frame: Week 4 after treatment initiation
Change in pruritus severity
Change in itching intensity measured by a verbal rating scale (0-4).
Time frame: 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).
Time frame: Baseline, week 2
Insomnia prevalence
Proportion of participants meeting the AIS cutoff for clinically significant insomnia.
Time frame: 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).
Time frame: 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).
Time frame: Through week 4
Direct treatment cost
Direct cost of the treatment course per participant, converted to US dollars.
Time frame: 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.
Time frame: Week 2
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Ran from Jun 2024 to primary completion in May 2026, 23 months.
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Studies of the drugs tested here: Sulfur · Permethrin
Can Tho University of Medicine and Pharmacy