Comparison of Topical Permethrin 5% and Spinosad 0.9% for Scabies Treatment
Comparison of the Efficacy of Topical Permethrin 5% and Spinosad 0.9% in the Treatment of Scabies: A Randomised Controlled Trial
The goal of this randomized controlled clinical trial is to compare the effectiveness of topical Permethrin 5% cream and Spinosad 0.9% suspension in treating scabies in patients aged 5-60 years.
The main questions it aims to answer are:
- Is there a difference in the effectiveness of topical Permethrin 5% and Spinosad 0.9% in treating scabies at Day 14?
- What are the treatment-related adverse effects of these two medications?
Researchers will compare the two treatment groups to determine whether there is a significant difference in treatment efficacy.
Participants will be randomly assigned to one of two groups:
- Group A will receive topical Permethrin 5% cream, applied from the neck to the toes for 8-12 hours, followed by washing. A second application will be given after 7 days.
- Group B will receive topical Spinosad 0.9% suspension, applied similarly, with repeat application only if clinically indicated.
Participants will be instructed regarding correct treatment application, hygiene measures, and treatment of close contacts. They will be assessed at baseline, Day 7, and Day 14.
The main outcome will be treatment efficacy at Day 14, defined as complete resolution of itching, healing of skin lesions, and absence of new lesions.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Scabies is a common parasitic skin infestation characterized by nocturnal itching and characteristic skin lesions. It can affect the quality of life of patients and may lead to secondary complications.
Topical Permethrin 5% is a standard treatment for scabies. Spinosad 0.9% is a topical ectoparasiticidal agent with a different mechanism of action. This study is designed to compare the efficacy of these two topical treatments in patients with clinically diagnosed scabies.
This study will be conducted as a randomized controlled trial in the Department of Dermatology. A total of 180 patients of either gender, aged 5-60 years, will be enrolled using non-probability consecutive sampling after fulfilling the predefined inclusion and exclusion criteria and providing informed written consent.
Participants will be randomly allocated into two groups using a computer-generated randomization method.
Group A will receive topical Permethrin 5% cream applied from neck to toe for 8-12 hours, followed by washing. A second application will be given after seven days.
Group B will receive topical Spinosad 0.9% suspension applied similarly, with repeat application only if clinically indicated.
Participants will be instructed regarding correct application technique, hygiene measures, and treatment of close contacts. Follow-up assessments will be conducted on Day 7 and Day 14.
Treatment efficacy will be assessed at Day 14 based on complete resolution of pruritus, healing of skin lesions, and absence of new lesions. Clinical response, visual analogue scale for pruritus, number of active lesions, new lesions, and treatment-related adverse effects will also be assessed.
Data will be analyzed using SPSS version 25. The Chi-square test will be used to compare treatment efficacy between the two groups. A p-value of 0.05 or less will be considered statistically significant.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Sabeen Riaz, MBBS
- 전화번호: +923157472819
- 이메일: drsabeenriaz907@gmail.com
연구 연락처 백업
- 이름: Tanzeela Khalid, MBBS, FCPS Dermatology
- 전화번호: +923336501571
- 이메일: tanzeelakhalid@tuf.edu.pk
연구 장소
-
-
Punjab Province
-
Faisalābad, Punjab Province, 파키스탄, 38000
- Madina Teaching Hospital
-
연락하다:
- Areeba Basharat, MBBS
- 전화번호: +923074396418
- 이메일: areebabasharat567@gmail.com
-
연락하다:
- Sabeen Riaz, MBBS
- 전화번호: +923157472819
- 이메일: drsabeenriaz907@gmail.com
-
수석 연구원:
- Sabeen Riaz, MBBS
-
부수사관:
- Areeba Basharat, MBBS
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients of either gender.
- Patients aged 5-60 years.
- Patients presenting with clinically diagnosed scabies, characterized by nocturnal pruritus and characteristic skin lesions such as burrows, papules, or nodules.
Exclusion Criteria:
- Patients with secondary bacterial infection requiring systemic antibiotics.
- Patients who have received anti-scabies treatment within the last four weeks.
- Patients with known hypersensitivity to permethrin or spinosad.
- Pregnant or lactating women.
- Patients with chronic dermatological conditions that may interfere with assessment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Group A - Permethrin 5%
Patients randomized to Group A will receive topical Permethrin 5% cream applied from neck to toe for 8-12 hours, followed by washing. A second application will be given after 7 days. |
Patients will receive topical Permethrin 5% cream applied from neck to toe for 8-12 hours followed by washing. A second application will be given after 7 days. |
|
실험적: Group B - Spinosad 0.9%
Patients randomized to Group B will receive topical Spinosad 0.9% suspension applied similarly. Repeat application will be performed only if clinically indicated. |
Patients will receive topical Spinosad 0.9% suspension. Repeat application will be performed only if clinically indicated. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of participants achieving treatment efficacy at day 14
기간: Day 14 after treatment initiation
|
Treatment efficacy will be defined as complete resolution of pruritus, healing of skin lesions, and absence of new lesions at day 14 after treatment initiation, as determined by clinical examination and patient-reported symptoms. The proportion of participants achieving treatment efficacy will be compared between the permethrin 5% and spinosad 0.9% groups. |
Day 14 after treatment initiation
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Tanzeela Khalid, MBBS, FCPS Dermatology, The University of Faisalabad
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- UMDC/IRB/34/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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