Apelin12 in Acne Vulgaris

March 26, 2018 updated by: Amira Abdelaziz, Assiut University

Serum apelin12 in Acne Vulgaris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Acne lesions may vary in number during the natural course of the disease and multiple measurements have been developed which is based on clinical examination and photographic documentation, to measure the clinical severity.

The Grading of acne based on the type of lesions, affected surface area and their severity that can help in deciding which therapies are needed in each individual. However, no grading system has been accepted universally. The Global Acne Grading System is a quantitative scoring system to assess the severity of acne. According to this score acne was graded as mild, moderate, severe and very severe.

The severity of acne was also graded using the Comprehensive Acne Severity Scale.

Adipokines are proteins that are synthesized and secreted primarily by adipocytes in response to various stimuli, include interleukin 6 and other small molecular weight bioactive proteins such as adiponectin, resistin, leptin, serpin E1 [also known as plasminogen activator inhibitor 1 and endothelial plasminogen activator inhibitor], visfatin (also known as nicotinamide phosphoribosyltransferase), apelin, chemerin, retinol binding protein 4, and monocyte chemoattractant protein 1.

Due to their different biological properties and diverse cellular targets adipokines are involved in a wide array of (patho)physiological processes and are responsible for mediating the inflammatory effects of the adipose tissue in the local tissue environment as well as to different organs via circulation. By detecting alterations in their serum levels also in dermatological diseases such as acne vulgaris and psoriasis, extensive studies have also started in dermatological research to identify the possible targets and the cutaneous sources of these proteins.

Apelin is an endogenous ligand of the previously discovered "orphan" receptor named APJ, isolated from bovine stomach extracts.

It is a product of apelin gene that is located on chromosome Xq25-26.1 and translated as a 77 amino acid prepropeptide. It is processed into several active molecular forms with different biological activities. Apelin belongs to adipokines group because its m-RNA expression has been demonstrated in mature adipocytes in rodents and humans.

Apelin peptide expression has been also demonstrated in several tissues and seems to have different regulatory functions, depending on the expressing tissue, the apelinergic system distribution over such a variety of tissues has suggested that it might play relevant roles in human physiology.

Apelin has been reported to have an effect on appetite, drinking behavior, angiogenesis, and the cardiovascular system. It is regulated by insulin. Apelin might be a novel target for preventing obesity and obesity-related diseases via enhancement of vascular integrity.

Several active apelin forms exist such as apelin-36, apelin-17, apelin-13, and apelin-12.

Apelin-12 is a 12-amino peptide fragment that has been implicated in reducing blood pressure via a nitric oxide mechanism, and is involved in feeding mechanisms via stimulation of cholecystokinin secretion.

It is considered to be one of the most potent isoform of apelin.

The studies evaluating the role of adipokines are very few in patient with acne vulgaris.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be performed at Department of Dermatology, Venereology and Andrology in Assiut University Hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
serum apelin12
Time Frame: 12 hour
blood samples will be taken then measurement of serum apelin12 by using ELISA technique after fasting 12 hours.
12 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12hour
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.
7hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAAA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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