Compare efficacy and safety of moxidectin and ivermectin in treatment of patients with scabies.
Design
This is a single-blind, Two parallel groups, randomized controlled Phase 2 trial
Settings and conduct
This study will be held in Tanta city, Gharbia, Egypt, patients attending at dermatology outpatient clinic in Tanta University hospital.
Scabies will be diagnosed by history, examination of skin to detect presence of burrows or excoriated papules or scratching marks in predilection sites, and detection of mites (Sarcoptes scabii) by microscopic examination.
Then, patients who will accept participation and sign an informed consent will be randomly allocated into two groups. Patients will be blinded by application of medication in containers marked A or B. After using either ivermectin or moxidectin, reevaluation will be made clinically and microscopically to compare the efficacy of both drugs.
Participants/Inclusion and exclusion criteria
The study will be carried out on patients attending the dermatology outpatient clinic
Inclusion criteria: Patients diagnosed with scabies: 1.Intense pruritus especially at night. 2.Typical distribution of the excoriated papulovesicular lesions 3.Affection of other family members 4.Detection of Sarcoptes Scabeii mites in cutaneous scrapings
Exclusion criteria: Patients with recent topical or systemic treatments of scabies; clinical bacterial infection or any other associated skin disease; evident systemic diseases causing pruritus; pregnant; and lactating
Intervention groups
Group A (50 patients): Treated by moxidectin (Cydectin®) once
Group B (50 patients): Treated by ivermectin (Iverzine®) once daily for 3 successive days
Main outcome variables
The treatment efficacy will be evaluated by clinical lesions, degree of pruritus and mites count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191030045275N1
Registration date:2020-02-20, 1398/12/01
Registration timing:prospective
Last update:2020-02-20, 1398/12/01
Update count:0
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Ahmad El-Ebiary
Name of organization / entity
Faculty of Medicine, Tanta University
Country
Egypt
Phone
+20 40 3350373
Email address
a.ebiary@med.tanta.edu.eg
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2641-08-23, 2020/06/01
Expected recruitment end date
2642-02-20, 2020/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Safety of moxidectin versus ivermectin for treatment of human scabies: A randomized clinical trial
Public title
Effect of moxidectin in treatment of scabies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
(A) Clinical: 1. Intense pruritus especially at night. 2. Typical distribution of the excoriated papulovesicular lesions; around umbilicus, flexures, genitalia, interdigital spaces. 3. Affection of other family members.
(B) Parasitological: By detection of Sarcoptes Scabeii mites (adult, larvae and eggs) in cutaneous scrapings.
Exclusion criteria:
Patients with recent topical or systemic treatments of scabies.
Patients with clinical bacterial infection or any other associated skin disease.
Patients with any evident systemic diseases causing pruritus.
Pregnant and lactating women.
Age
To 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
We used the sealed, opaque sequentially numbered envelopes method for randomization and allocation concealment of patients included in this trial. We used 100 identical, opaque, letter-sized envelopes. We used 2 rolls of household aluminum cooking foil that we cut into 100 sheets (of the same
width as and twice the height of the envelope). We prepared 100 envelope-sized sheets of white paper and 100 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 50 paper sheets and “Treatment B” on the other 50 sheets. To prepare 50 Treatment A envelops, we selected one envelope-sized sheet of of Treatment A and placed one sheet of carbon paper on top of the Treatment A allocation paper with the carbon side facing the paper, then we put both papers inside a foil wrapper. Then, the completed insert was placed into a blank envelope with the carbon paper closest to the front of the envelope. Finally, the envelop was sealed and we signed across the seal. We completed all the 50 Treatment A envelops the same way. We prepared 50 Treatment B envelops the same way as Treatment A envelops.
Both sets of envelops were combined and we shuffled them thoroughly. Then, using a pen we marked a number on the front of each envelope sequentially from 1 to 100. The carbon paper inside the envelope will transfer this number to the allocation paper inside. Finally, we placed these envelopes into a plastic container, in numerical order, ready for use.
Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care 2005;20:187–93.
Blinding (investigator's opinion)
Single blinded
Blinding description
This trial is a single blind study for the participant involved. We will achieve this by making a letter for each medication used and masking the name of the medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tanta Faculty of Medicine
Street address
El-Giesh Street, Medical Campus of the Faculty of Medicine, Tanta University
City
Tanta
Postal code
31527
Approval date
2640-08-03, 2019/05/12
Ethics committee reference number
33106/ 05/19
Health conditions studied
1
Description of health condition studied
patients diagnosed of having scabies
ICD-10 code
B86
ICD-10 code description
Scabies
Primary outcomes
1
Description
Clinical lesions and degree of pruritus
Timepoint
1 week after intervention
Method of measurement
Clinical evaluation
2
Description
Mites count
Timepoint
1 week after intervention
Method of measurement
Microscopic examination of mites
Secondary outcomes
empty
Intervention groups
1
Description
Group A (50 patients): Treated by application of topical formulation of moxidectin (Cydectin®) once.
Category
Treatment - Drugs
2
Description
Control group: Group B (50 patients): Treated by application of topical ivermectin (Iverzine®) once per day for 3 successive days.