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Apelin12 in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480503
Recruitment Status : Unknown
Verified March 2018 by Amira Abdelaziz, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Amira Abdelaziz, Assiut University

Brief Summary:

Acne vulgaris is a common chronic inflammatory disease of the pilosebaceous unit which is characterized by the formation of non-inflammatory open and closed comedones and inflammatory papules, pustules, nodules and cysts.

It is a multifactorial disease that affects mostly adolescent population. Acne appears very early in puberty during the preteen years, often before menarche in girls. Because many adolescents have acne, it is difficult to predict which individuals are prone to severe cases.

The pathogenesis of acne is complex, with strong evidence supporting the involvement of follicular hyperkeratinization, hyperactivity of the sebaceous glands, colonization of Propionibacterium acnes and yeast, and inflammation. Although the importance of androgens in the pathophysiology of acne has been supported by both clinical studies and experimental data, the research evaluating adipokines are very few in patients with acne vulgaris.


Condition or disease
Acne Vulgaris

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Serum apelin12 in Acne Vulgaris
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Group/Cohort
study group
Patients with acne vulgaris , measurement of serum apelin12 by using ELISA technique ,complete lipid profile and fasting blood glucose.
Control group
Healthy control volunteers, measurement of serum apelin12 by using ELISA technique ,complete lipid profile and fasting blood glucose.



Primary Outcome Measures :
  1. serum apelin12 [ Time Frame: 12 hour ]
    blood samples will be taken then measurement of serum apelin12 by using ELISA technique after fasting 12 hours.


Secondary Outcome Measures :
  1. Complete lipid profile. [ Time Frame: 12hour ]
    blood samples will be taken and complete lipid profile will be measured after fasting 12 hours by biochemical measurement.

  2. Fasting blood glucose [ Time Frame: 7hours ]
    blood samples will be taken and fasting blood glucose level will be measured after fasting 7 hours by biochemical measurement method.


Biospecimen Retention:   Samples With DNA

The venous blood sample will be taken from acne patients and control group after fasting for 10-12 hours and the following will be done:

Fasting blood glucose. Complete lipid profile. Serum level of apelin-12 will be measured using enzyme linked immunosorbent assay(ELISA) technique .



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study will be performed at Department of Dermatology, Venereology and Andrology in Assiut University Hospital.
Criteria

Inclusion Criteria:

  • Acne vulgaris patients from different ages and sex.

Exclusion Criteria:

  • Pregnant and lactating females.
  • Local cutaneous infection or any other dermatological diseases.
  • Diabetic patients or severe systemic disease such as liver and renal failure.

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): NCT03480503


Contacts
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Contact: Doaa Abu taleb, lecturer 01001463937 Dodda_aboutaleb@yahoo.com
Contact: Eman Kamal, assis prof 01005369338 emohanya@yahoo.com

Sponsors and Collaborators
Assiut University
Publications:

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Responsible Party: Amira Abdelaziz, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03480503    
Other Study ID Numbers: SAAA
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Amira Abdelaziz, Assiut University:
Apelin12
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases