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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03602534
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : July 31, 2018
Information provided by (Responsible Party):
Diana Gamal Esmat Fouad Botros, Assiut University

Brief Summary:

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 .

Condition or disease
Acne Vulgaris Thyroid Dysfunction

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.

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Study Type : Observational
Estimated Enrollment : 79 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Thyroid Dysfunction in Female Patients With Acne Vulgaris: [ Relation to Other Variables ]
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

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

Primary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples Without DNA
blood samples (serum)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • multi centers in Assiut city
  • females only
  • age starts from 16 years

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.

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 identifier (NCT number): NCT03602534

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Contact: Emad Taha 01006462294
Contact: Reham Abdel-Gaber 01005043777

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Assiut, Egypt
Contact: Reham Abdel-Gaber    01005043777   
Sponsors and Collaborators
Assiut University
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Study Director: Emad Taha Assiut University
Additional Information:

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Responsible Party: Diana Gamal Esmat Fouad Botros, Principle Investigator, Assiut University Identifier: NCT03602534    
Other Study ID Numbers: TDFAV
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 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 Diana Gamal Esmat Fouad Botros, Assiut University:
acne vulgaris
thyroid dysfunction
Additional relevant MeSH terms:
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Acne Vulgaris
Thyroid Diseases
Endocrine System Diseases
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases