Thyroid Dysfunction in Female Patients With Acne Vulgaris: [ Relation to Other Variables ]

July 28, 2018 updated by: Diana Gamal Esmat Fouad Botros, Assiut University

Acne is a chronic inflammatory disease of the pilo-sebaceous unit with a multi-factorial etiology. It is one of the most frequent cutaneous diseases, affecting more than eighty percent of the population at some point in their lives .

Endocrine factors especially androgens and steroids are one of multiple factors provoked to be involved in pathogenesis of acne . Thyroid hormones have steroid like action that have many regulatory functions in many body organ functions including skin and pilosebaceous unit. Furthermore, subtle thyroid dysfunction was shown to have a role in many disease conditions.

Thyroid hormone action on sebaceous glands is unclear. In hypothyroid states, sebocytes exhibit reduced rates of secretion that increases with thyroxine administration .

Study Overview

Status

Unknown

Conditions

Detailed Description

Most of studies about thyroid dysfunction in acne patients focused on adult acne population especially females and searched for presence or absence of associating anti-thyroid antibodies with controversial results .

Some other studies were concerned with the impact of acne treatments as tetracycline, isotretinoin or radiotherapy on thyroid pathologies and dysfunction .

Global Acne Severity Scale (GAGS) is a simple, accurate, fast method for the determination of severity of acne, and it requires no special equipment and is relatively cost-effective. Its personal and interpersonal differences is low and it was first used by Doshi and his colleagues in 1997 in USA .

To the best of knowledge, little is published about thyroid dysfunction in acne female patients of different age categories and correlating thyroid function with other important patient and acne variables as body mass index (BMI) , age (starting from 16 years) , acne type, severity and duration.

Study Type

Observational

Enrollment (Anticipated)

79

Contacts and Locations

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

Study Locations

  • Egypt
      • Assiut, Egypt
        • DGamal

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

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

  • multi centers in Assiut city
  • females only
  • age starts from 16 years

Description

Inclusion Criteria:

  • Patient with acne vulgaris from females only with different ages (starting from 16 years) , BMI groups.

Exclusion Criteria:

  • Female patients with clinically diagnosed thyroid disease.
  • Female patients receiving isotretinoin or minocycline in the last 6 months
  • Female patients who were subject to radiotherapy or surgery in neck region.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
cases with variable acne severity scores
  • group will include 50 females
  • Clinical examination including acne grade assessment using Global Acne Grading Scale (GAGS)
  • Assessment of body mass index (BMI)
  • blood serum samples will be collected from all patients to do thyroid function test
healthy controls
  • group will include 29 females
  • Assessment of body mass index (BMI)
  • blood serum samples will be collected from all healthy controls to do thyroid function test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thyroid hormone level in female acne vulgaris patients
Time Frame: 1 hour
Peripheral blood samples will be taken , for measurement of thyroid hormone by ELISA
1 hour

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Emad Taha, 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

Helpful Links

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)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 28, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDFAV

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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