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Review the effectiveness of omeprazole and doxycycline with erythromycin topical solution 4% in the treatment of acne vulgaris lesions

Protocol summary

Summary
Objective: To assess the effectiveness of omeprazole and erythromycin topical solution with 4% doxycycline in the treatment of acne vulgaris lesions. Design: This study is a randomized clinical trial (Randomized Clinical Trial) and studied, patients with moderate acne lesion will.Setting & control: Patients were randomly assigned to two groups, one group treated with omeprazole plus 4% solution of topical erythromycin and doxycycline second group treated with topical 4% erythromycin solution, were treated for three months Before treatment, all patients will be tested for H. pylori.Participation including:The diagnosis of acne average = Score EGGS 3; lack of sensitivity to macrolides and proton pump inhibitors; lack of active liver disease or kidney; Not taking warfarin; Phenytoin, diazepam; Older than 12 years; 17 to 40 inflammatory lesions (papules, nodules, pustules) and 20 to 100 comedone closed or open Bashnd.Intervention:omeprazole 20 mg tablet daily with 4% Erytrvmasyn 4% solution Pak Daru 2-doxycycline capsules 100 mg daily with 4% Erythromycin solution Pak Daru.Main outcome measures: Demographic characteristics of patients, skin and non-skin side effects, location withdrawals, the number of inflammatory lesions (papules, pustules and comedone), inflammatory lesions responded to treatment and the level of satisfaction (questionnaire).Patients at weeks 2, 4, 6, 8, 10 and 12 be evaluated.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016012625916N3
Registration date: 2016-03-14, 1394/12/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-14, 1394/12/24
Registrant information
Name
Fariba Jaffary
Name of organization / entity
Skin disease & Leishmaniasis Research Center-Seddigheh Tahereh Center
Country
Iran (Islamic Republic of)
Phone
+98 33373736
Email address
jaffary@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review the effectiveness of omeprazole and doxycycline with erythromycin topical solution 4% in the treatment of acne vulgaris lesions
Public title
Effect of omeprazole and doxycycline with erythromycin topical solution 4% for the treatment of acne lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included a diagnosis of acne = Score EGGS 3; insensitivity to macrolides and proton pump inhibitors: lack of active liver or kidney disease; avoiding the use of warfarin; phenytoin; diazepam:Older than 12 years;17 to 40 inflammatory lesions (papules, nodules, pustules);20 to 100; closed or open comedones .Exclusion criteria:patients with criteria for pregnancy and lactation; allergic reactions to medications; exacerbation;Astringent and topical abrasive consumption one week before the start of treatment;topical treatment of acne products; including soaps; antimicrobial consumption and comedogenic products for 2 weeks before treatment;The use of topical retinoids; retinol and systemic acne treatments one month before treatment; the use of systemic retinoids 6 months befor of treatment;oligomenorrhea;Hirsutism;taking OCP; systemic antibiotics for at least 1 month before treatment;fulminant;body acne alone.
Age
From 12 years old to 44 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street thousand acres
City
Isfahan
Postal code
Approval date
2010-03-14, 1388/12/23
Ethics committee reference number
288280

Health conditions studied

1

Description of health condition studied
Acne volgaris
ICD-10 code
l00- l08
ICD-10 code description
infectios of the skin and subcutaneos tissue

Primary outcomes

1

Description
The clinical remission and response to treatment of inflammatory lesions.
Timepoint
Patients at weeks 2, 4, 6, 8, 10 and 12 will be evaluated
Method of measurement
the improvement of clinical acne, severity and response to treatment of inflammatory lesions (80% and above = good - between 50 and 79% = middle = 20% and down 49% = less = no response) to be discussed.

Secondary outcomes

1

Description
Side effects
Timepoint
Weeks 2, 4, 6, 8, 10 and 12
Method of measurement
History and clinical observation

Intervention groups

1

Description
Intervention group 1: 34 patients will be treated with tablets omeprazole 20 mg (one a day) with a solution of erythromycin topical 4%Pak Daru (twice daily)
Category
Treatment - Drugs

2

Description
Control group:34 atients will be treated with Doxycycline 100 mg capsule daily with 4% Erythromycine solution Pak twice daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin Disease & Leishmaniasis Research Center
Full name of responsible person
Dr.Fariba Jaffary
Street address
Street Khorram - Tahereh. Seddigheh. Research Center
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Akram Mazaheri
Street address
Hezar Jrib Street, Isfahan University of Medical Sciences and Health Services, Building No. 4 of Vice, Vice chancellor for research
City
Isfahan
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, Isfahan 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
Skin disease & Leishmaniasis Research Center
Full name of responsible person
Hanieh Sharifian
Position
MS-Researcher
Other areas of specialty/work
Street address
Street Khorram, Jomhuri Square, Skin disease & Leishmaniasis Research Center, Seddigheh Tahereh
City
Isfahan
Postal code
Phone
+98 31 3337 3736
Fax
Email
hany.sharifian@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin Disease & Leishmaniass Research Center
Full name of responsible person
Dr.Fariba Jaffary
Position
PHD Pharmacology,Associate Professor
Other areas of specialty/work
Street address
Khorram Street, Jomhuri Square, Skin Disease & Leishmaniass Research Center-Seddigheh Tahereh
City
Isfahan
Postal code
Phone
+98 31 3337 3736
Fax
Email
jaffary@pharm.mui.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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