Comparison of Efficacy Permethrin 5% Cream with Ivermectin 1% Cream in Combination with Oral Doxycycline in Treatment of Papulopustular Rosacea Patients
Comparison of Efficacy Between Permethrin 5% Cream and Ivermectin 1% Cream in Combination with Oral Doxycycline in Treatment of Papulopustular Rosacea Patients
Design
Clinical trial has 2 groups of 20 people and parallel,double blind,randomized,phase 3 on 40 patients.for randomization is used from statistic software
Settings and conduct
The Papulopustular Rosacea patients is photographed before and after treatment by Permetrin cream5% or Ivermectin cream1% in Alzahra Hospital.Patients and consequence evaluator are blinded in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Diagnosis of typical papulopustular rosacea according two dermatologists and performance biopsy if rosacea is suspected
2-No treatment with topical steroids or other topical treatment during 14 days before starting study
3-No treatment with any systemic drugs by known effect on inflammation responses during 30 days before starting study
4-No treatment with topical retinoids during 30 days ago or systemic retinoids during 180 days before starting study
5-No treatment by physical modality that effect on rosacea lesions during 30 days before starting study
6-Absence of other cutaneous diseases that interfere with assessment lesions related to rosacea
7-Absence of comedon, cyst and scar that benefit to diagnosis of acne vulgaris
8-Absence of pregnancy and breastfeeding
Exclusion criteria:
1-Less than 18 years
2-Male gender
Intervention groups
Comparison of Efficacy Between Permethrin 5% Cream in one group of 20 people and Ivermectin 1% Cream in Combination with Oral Doxycycline in one group of 20 people in Treatment of Papulopustular Rosacea Patients.any body of groups should papulopustular rosacea individuals over 18 years
Main outcome variables
Increase or decrease number and severity after use Ivermectin 1% cream or permetrin 5% cream
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210729052010N1
Registration date:2021-12-24, 1400/10/03
Registration timing:prospective
Last update:2021-12-24, 1400/10/03
Update count:0
Registration date
2021-12-24, 1400/10/03
Registrant information
Name
Mohammaddavood Zomorodian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 8244
Email address
zomorodianmd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Efficacy Permethrin 5% Cream with Ivermectin 1% Cream in Combination with Oral Doxycycline in Treatment of Papulopustular Rosacea Patients
Public title
Comparison of Efficacy Permethrin topical Cream in Combination with Doxycycline Tablet with Ivermectin topical Cream in Combination with Doxycycline Tablet in Treatment of cutaneus disease Rosacea Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of typical papulopustular rosacea according two dermatologists and performance biopsy if rosacea is suspected
No treatment with topical steroids or other topical treatment during 14 days before starting study
No treatment with any systemic drugs by known effect on inflammation responses during 30 days before starting study
No treatment with topical retinoids during 30 days ago or systemic retinoids during 180 days before starting study
No treatment by physical modality that effect on rosacea lesions during 30 days before starting study
Absence of other cutaneous diseases that interfere with assessment lesions related to rosacea
Absence of comedon, cyst and scar that benefit to diagnosis of acne vulgaris
Absence of pregnancy and breastfeeding
Exclusion criteria:
Less than 18 years
Male gender
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
For Randomization is used from table of random numbers.in this study there is two treatment groups(treatment by permetrin 5% cream=A and treatment by Ivermectin 1% cream=B).every odd number an assignment to A and every even number an assignment to B.we close our eyes and put a finger anywhere on the table and write the column and row number that will our starting point and also write the direction we wil move in the table from starting point horizentally to the left.then we will write assignmented treatment by intended randomized number and when the first patient will enroll,the first assignmented treatment will be done and second treatment for second patient and so on.when the number of group A or B patients completed,we forced assign the rest of number of patients to notcompletedgroup.although it is possible to create equal vigesimal groups that in this case does not need to do above way. in this way ,treatment assignment for next patient is not predictable.In this study the patients have equal chance for selection in one of two intervention groups.In this study we don’t use from stratified randomization for example patients of case study don’t grouping based on sex and agenand other factors.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Drugs is delivered by pharmacist in similar tubes but coded tube without information of the treating physician and patients from the type of drugs
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Soffe Ave., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2020-09-04, 1399/06/14
Ethics committee reference number
IR.MUI.MED.REC.1399.456
Health conditions studied
1
Description of health condition studied
Rosacea papulopustular disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increase or decrease number and severity after use Ivermectin 1% cream or permetrin 5% cream
Timepoint
0,6 and 12 weeks after starting treatment
Method of measurement
Photography from lesions and remission of lesions
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group:use of permethrin 5% topical cream produced by Gilan daroo company for 12 weeks on cutaneus lesions for 20 papulopustular rosacea patients and photography from their cutaneus lesions in 0 and 6 and 12 weeks after treatment and compare photos together
Category
Treatment - Drugs
2
Description
second Intervention group:use of Ivermectin 1% topical cream produced by Gilan daroo company for 12 weeks on cutaneus lesions for 20 papulopustular rosacea patients and photography from their cutaneus lesions in 0 and 6 and 12 weeks after treatment and compare photos together
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Nazila Poostiyan
Street address
Soffe Ave., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Poostiyan
Street address
Soffe Ave., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Poostiyan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Soffe Ave., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Poostiyan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Soffe Ave., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Poostiyan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Soffe Ave., Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparison of Efficacy Between Permethrin 5% Cream and Ivermectin 1% Cream in Combination with Oral Doxycycline in Treatment of Papulopustular Rosacea Patients
When the data will become available and for how long
It will be published as soon as the research project is completed
To whom data/document is available
Every body
Under which criteria data/document could be used
In order to inform and under any circumstances
From where data/document is obtainable
To the site
What processes are involved for a request to access data/document