Evaluation of the treatment of rosacea patients after eradication of Helicobacter pylori infection and treatment with topical gel of metronidazole 75% in comparison with control.
Determining the improvement of rosacea patients after Helicobacter pylori infection eradication and treatment with topical gel of metronidazole 75% compared to control.
Design
This randomized clinical trial study will be performed in 2021 at Skin Diseases and Leishmaniasis Research Centre in Isfahan city. First, ELISA test (to determine the level of IgG and IgM against Helicobacter pylori) and EIA test (to determine Helicobacter pylori antigen in the stool) will be performed for 62 patients with rosacea.
Settings and conduct
This randomized clinical trial study will be performed in 2021 at Skin Diseases and Leishmaniasis Research Centre in Isfahan city. After confirmation of Helicobacter pylori infection, patients are randomly divided into two groups: As, in the intervention group , in addition to the standard treatment with topical gels, 3 antibiotics are applied for two weeks in order to eradicate the infection. In comparisongroup only treatment with topical gels will be prescribed. After completion of treatment in both intervention and comparison groups, ELISA(enzyme-linked immunosorbent assay) and EIA (enzyme-linked immunosorbent assay) tests will be repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Ages 17-65
2) Subjects with Rosacea
Exclusion criteria:
1) Gastrointestinal symptoms
2) Age less than 17 and more than 65
3) Pregnancy or breastfeeding
4) Antibiotics (Bismuth subsalicylate)
6) Use of proton pump inhibitors (Nexium and Prilosec) during the one month before the start of the study.
Intervention groups
The intervention group, in addition to standard treatment with topical gels, receives triple antibiotics. The comparison group uses only therapy with topical gels.
Main outcome variables
H. pylori antigen, IgM against H. pylor, IgG against H. pylori
Lesion area.
General information
Reason for update
Acronym
HP
IRCT registration information
IRCT registration number:IRCT20201116049400N1
Registration date:2021-07-30, 1400/05/08
Registration timing:registered_while_recruiting
Last update:2021-07-30, 1400/05/08
Update count:0
Registration date
2021-07-30, 1400/05/08
Registrant information
Name
seyed hossein hejazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9173
Email address
hejazi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the treatment of rosacea patients after eradication of Helicobacter pylori infection and treatment with topical gel of metronidazole 75% in comparison with control.
Public title
The effect of eradication of Helicobacter pylori infection in the treatment of rosacea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 17-56
Subjects with rosacea
Exclusion criteria:
Gastrointestinal symptoms (bloating, nausea, high intestinal upset, premature satiety, heartburn, ...)
Age less than 17 and more than 65 years
Antibiotics ( Bismuth subsalicylate) for the treatment of Helicobacter pylori eradication
Use of proton pump inhibitors (Nexium and Prilosec) during the month before the start of the study
Pregnancy or Breastfeeding
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
After confirmation of Helicobacter pylori infection in patients with rosacea, they are divided into two groups based on restricted simple randomization of block randomization.: group 1 (intervention) and group 2 (comparison).
Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to ensure that the number of samples assigned to each of the study groups is equal in cases where intermediate analyzes are required during the sampling process. The size of all blocks is equal and in this two-group experiment ,we will have 20 blocks (including 3 participants in the intervention group and 3 participants in the control group).
For randomization tools, random allocation software is used. These random sequence generation software, in addition to simple randomization, are able to generate random sequences by blocking method.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.MUI.MED.REC.1399.628
Health conditions studied
1
Description of health condition studied
Rosacea
ICD-10 code
L71
ICD-10 code description
Rosacea
Primary outcomes
1
Description
Determination of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) levels of Helicobacter pylori and qualitative determination of Helicobacter pylori antigens
Timepoint
Measurement of IgG and IgM levels of Helicobacter pylori , evaluation of the presence of Helicobacter pylori antigen in the feces of patients and lesion size (before the intervention) and 2 months after the start of topical antibiotics and gels.
Intervention group: In addition to the standard treatment with Metro Nidazole 75% topical gel (Metromax produced by Tehran Shimi Company) (twice a day), in order to eradicate the infection for two weeks, triple antibiotic treatment with clarithromycin 500 mg (twice a day) (Pharmacy Laboratory) Day of medicine), amoxicillin 1 g (twice a day) (Kosar Pharmaceutical Company) and omeprazole 20 mg (twice a day) (Sanamad Pharmaceutical Company) are applied.
Category
Treatment - Drugs
2
Description
Control group: In the case of the comparison (control) group, treatment with topical metronidazole 75% gel (twice daily) (Metromax produced by Tehran Shimi Company) will be prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Leishmaniasis And Skin Diseases Research Center
Full name of responsible person
Dr. Zabih Allah Shahmoradi
Street address
Jomhoori Square , Khoram Street, Sedighe And Tahereh Clinic
City
Isfahan
Province
Isfehan
Postal code
81876- 98191
Phone
+98 31 3335 9090
Email
emrc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Hagh Jooi Javanmard
Street address
Isfahan, Iran.Khoram St,Jomhouri
City
Isfahan
Province
Isfehan
Postal code
81876- 98191
Phone
+98 31 3335 9090
Email
dr.shahmoradi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Isfahan 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
Dr. Seyed Hossein Hejazi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Hezar Jarib Street, Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 9173
Email
hejazi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Hossein Hejazi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Hezar Jarib Street, Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶.
Phone
+98 31 3792 9173
Email
hejazi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Aghaei
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Tohid Street-Sadi Blind.N 9
City
Isfahan
Province
Isfehan
Postal code
8173963181
Phone
+98 31 3626 2206
Email
maryam.aghaei2008@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available