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Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03411733
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Dina Ali, Sohag University

Brief Summary:
The objective of the study is to investigate prevalence of H.Pylori infection among acne vulgaris patients.

Condition or disease Intervention/treatment
Helicobacter Pylori Infection Acne Vulgaris Other: Blood and stool samples collection

Detailed Description:

The study included patients with acne vulgaris and healthy control participants. The study recruited both sexes, all grades of acne, adolescents and young adults.

All patients were subjected to complete history, general and skin examination Acne vlugaris Patients were classified into mild, moderate and severe according to the classification of American Academy of dermatology for acne vulgaris.

Detection of H. pylori infection:

Blood and stool samples were taken from each participant and was directly transferred to laboratory for detection of H. Pylori antigen and antibody.

An enzyme-linked immune sorbent assay (ELISA) was used for quantitative assessment of IgG antibodies against H.Pylori in human serum.

A monoclonal antibodies based enzyme-linked immunosorbent assay was used to detect H.Pylori specific antigen in stool samples.


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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Helicobacter Pylori in Patients With Acne Vulgaris
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Group/Cohort Intervention/treatment
acne vlugaris group
Included recruited patients with acne vulgaris Intervention: Blood and stool samples collection
Other: Blood and stool samples collection
Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection

Control group
Included healthy participants Intervention: Blood and stool samples collection
Other: Blood and stool samples collection
Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection




Primary Outcome Measures :
  1. H.pylori infection [ Time Frame: one year ]
    Prevalence of H.pylori infection among acne group and control group


Biospecimen Retention:   Samples Without DNA
Blood and stool samples were retained for a short period (few hours) till completion of laboratory analyses


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with acne vulgaris and presented to Dermatology outpatient clinic, Sohag University hospital.

Healthy volunteers.

Criteria

Inclusion Criteria:

  • Acne vulgaris patients
  • Healthy volunteers (control)

Exclusion Criteria:

  • Patients with a history of drug intake that affects H. Pylori such as proton-pump inhibitors, clarithromycin, tetracyclines, amoxicillin or metronidazole within previous two weeks were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411733


Locations
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Egypt
Dermatology outpatient clinic, Sohag University Hospital
Sohag, Egypt, 82524
Sponsors and Collaborators
Sohag University
Investigators
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Study Director: Ramadan Saleh, MD Sohag Faculty of Medicine

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Responsible Party: Dina Ali, Resident physician, Department of Dermatology, Sohag Educational Hospital, Sohag University
ClinicalTrials.gov Identifier: NCT03411733     History of Changes
Other Study ID Numbers: HPAV001
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All available data shall be shared with other researchers upon their request after agreement of study director

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dina Ali, Sohag University:
acne vlugaris
prevalence
Helicobacter Pylori
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases