Comparing Sulfur to Different Regimes of Permethrin for the Treatment of Scabies

UDMS-Dermatology-06-2022

In 2017, the World Health Organization (WHO) labeled scabies as a neglected tropical disease. It is a serious health problem especially in poor developing countries like Syria, where overcrowding, poverty, and war consequences are considered major factors for spreading the disease. Permethrin lotion or cream is the treatment of choice for scabies, and it is applied once a week for two consecutive weeks according to the global guidelines. However, most practitioners in Syria do not adhere to this standard regimen, and a variety of regimens are used instead based mostly on clinical experience. In this study, the investigators are comparing four different regimens of permethrin application and comparing Sulfur to permethrin in terms of efficacy and safety.

2022-03-15

2022-09-15

2022-11-12

Completed

Early phase I

250

Inclusion Criteria: * Scabies participants who meet "The 2020 International Alliance for the Control of Scabies (IACS) Consensus Criteria" level A or B. * Participants can apply the treatment themselves or by their guardians if they are children. * Participants willing to commit to the study's requirements Exclusion Criteria: * Participants are younger than two years. * Participants with other skin diseases that could interfere with their assessment. * Participants who received treatment for scabies in the preceding month. * Receiving treatment with corticosteroids in the preceding week. * Pregnancy, planning for pregnancy during the study, or breastfeeding. * Systemic infection or receiving systemic therapy for an infectious disease * Immunocompromised Participants. * Participants with crusted/Norwegian scabies. * Having sensitivity or allergy to permethrin or sulfur. * Participants with abnormal liver and kidney functions, thyroid disease, cardiac disorders, psychiatric illnesses. * Participation of a family member, or another member of the household in the current study. * The number of participants' households is seven or more.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of the five groups (Permethrin 5% P1, P2, P3, P4, and sulfur S).\n\nParticipants will be followed every two weeks for a month to evaluate primary and secondary outcomes.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 250, 'type': 'ACTUAL'}}

2024-05-02