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Trial record 63 of 231 for:    acne AND Percent

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

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ClinicalTrials.gov Identifier: NCT03602534
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Diana Gamal Esmat Fouad Botros, Assiut University

Tracking Information
First Submitted Date July 19, 2018
First Posted Date July 27, 2018
Last Update Posted Date July 31, 2018
Estimated Study Start Date December 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03602534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thyroid Dysfunction in Female Patients With Acne Vulgaris: [ Relation to Other Variables ]
Official Title Thyroid Dysfunction in Female Patients With Acne Vulgaris: [ Relation to Other Variables ]
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 .

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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood samples (serum)
Sampling Method Probability Sample
Study Population
  • multi centers in Assiut city
  • females only
  • age starts from 16 years
Condition
  • Acne Vulgaris
  • Thyroid Dysfunction
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 19, 2018)
79
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Emad Taha 01006462294 emadtaha76@yahoo.com
Contact: Reham Abdel-Gaber 01005043777 rehamaher707@yahoo.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03602534
Other Study ID Numbers TDFAV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Diana Gamal Esmat Fouad Botros, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Director: Emad Taha Assiut University
PRS Account Assiut University
Verification Date July 2018