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NCT03411733 Clinical Trial

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

Acne Vulgaris Clinical Trial

Official title:
Prevalence of Helicobacter Pylori in Patients With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03411733
Other study ID # HPAV001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date March 1, 2018

Study information
Verified date April 2018
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date March 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood and stool samples collection
Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection

Locations
Country Name City State
Egypt Dermatology outpatient clinic, Sohag University Hospital Sohag

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary H.pylori infection Prevalence of H.pylori infection among acne group and control group one year
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