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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sabeen Riaz, MBBS
- Telefonnummer: +923157472819
- E-post: drsabeenriaz907@gmail.com
Studera Kontakt Backup
- Namn: Tanzeela Khalid, MBBS, FCPS Dermatology
- Telefonnummer: +923336501571
- E-post: tanzeelakhalid@tuf.edu.pk
Studieorter
-
-
Punjab Province
-
Faisalābad, Punjab Province, Pakistan, 38000
- Madina Teaching Hospital
-
Kontakt:
- Areeba Basharat, MBBS
- Telefonnummer: +923074396418
- E-post: areebabasharat567@gmail.com
-
Kontakt:
- Sabeen Riaz, MBBS
- Telefonnummer: +923157472819
- E-post: drsabeenriaz907@gmail.com
-
Huvudutredare:
- Sabeen Riaz, MBBS
-
Underutredare:
- Areeba Basharat, MBBS
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of participants achieving treatment efficacy at day 14
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Tanzeela Khalid, MBBS, FCPS Dermatology, The University of Faisalabad
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UMDC/IRB/34/26
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