Objectives: The aim of this study is to determinate the effects of H. pylori eradication on patients suffering Rosacea who, at the same time, have clinical and serological evidence of H. pylori infection.
Design, Setting and Conduct: This non-randomized clinical trial study will be taken place in Gastrointestinal diseases department of Tabriz Emam Reza educational-clinical center during 6 months (August 2015-March 2016)
Participants including major eligibility criteria: 150 patients who are 20-65 years old and suffering rosacea and h.pylori infection will be randomly selected and included in study , while excluding pregnant patients or those suffering an co-existing dermatologic problem.
Intervention: All patients will undergo a precise assessment of rosacea condition using Duluth Rosacea Scoring Scale by a dermatologist. These patients will undergo a standard two-week course of treatment for H. pylori infection which includes metronidazole 500 mg orally twice a day, clarithromycin 500 mg orally twice a day, and pantoprazole 40 mg orally daily. All patients after undergoing eradication protocol will be assessed once more 60 days later by the dermatologist to examine Rosacea stage.
Main outcome measures: outcome measurements will be made at the beginning (day 0) and the end of the trial (day 60) by a dermatologist using the Duluth Rosacea Scoring Scale. At last before and after therapy Duluth Rosacea Scores will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051418946N3
Registration date:2015-06-29, 1394/04/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-06-29, 1394/04/08
Registrant information
Name
Reza Piri
Name of organization / entity
Emam Reza educational-medical center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 5372
Email address
reza.piri@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Helicobacter pylori eradication on patients suffering rosacea: a clinical trial study
Public title
Effect of Helicobacter pylori eradication on patients suffering rosacea: a clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: confirmed H.pylori infection; Suffering Rosacea.
Exclusion criteria:patients older than 65 and younger than 20; Existanse of any other dermatologic problem; patients refusal to continue study in any stage of study; allergy to clarithromycin, omeprazole; pregnant or breast-feeding; antibiotic therapy within the past 2 months; topical treatment of rosacea in past 3 weeks
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
5/4/854
Health conditions studied
1
Description of health condition studied
Rosacea
ICD-10 code
L71
ICD-10 code description
Rosacea
Primary outcomes
1
Description
Duluth Rosacea Scoring Scale
Timepoint
Before eradication- 60 days after study beginning
Method of measurement
Assessing by dermatologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:These patients will undergo a standard two-week course of treatment for H. pylori infection which includes metronidazole 500 mg orally twice a day, clarithromycin 500 mg orally twice a day, and pantoprazole 40 mg orally daily. All patients after undergoing eradication protocol will be assessed once more 60 days later by the dermatologist to examine Rosacea stage.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza medical-educational centre, Tarbiz University of medical sciences
Full name of responsible person
Dr.Parviz Saleh
Street address
Emam Reza educational-medical centre, Golgasht street, Azadi Avenue
City
Tarbiz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Central campus of Tabriz University of Medical Sciences, Golgasht street, Azadi avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Emam Reza educational-medical center
Full name of responsible person
Dr.Parviz Saleh
Position
Associate professor of tropical and infectious diseases
Other areas of specialty/work
Street address
Emam Reza educational-medical center, Azadi street, Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 41 3337 5411
Fax
Email
p.zzss@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Emam Reza educational-medical center
Full name of responsible person
Dr. Parviz Saleh
Position
Associate professor of tropical and infectious diseases
Other areas of specialty/work
Street address
Emam Reza educational-medical centre, Golgasht street, Azadi Avenue
City
Tabriz
Postal code
Phone
+98 41 3337 5411
Fax
Email
p.zzss@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Emam Reza educational-medical center
Full name of responsible person
Reza Piri
Position
Medical student
Other areas of specialty/work
Street address
Emam Reza educational-medical centre, Golgasht street, Azadi Avenue
City
Tabriz
Postal code
5154986444
Phone
+98 41 3334 5372
Fax
Email
reza.piri@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)