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

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03602534

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 ]

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

thyroid hormone level in female acne vulgaris patients [1 hour]
Peripheral blood samples will be taken , for measurement of thyroid hormone by ELISA

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DGamal	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Emad Taha, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

for calculation of sample size

Publications

Responsible Party:

Diana Gamal Esmat Fouad Botros, Principle Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03602534

Other Study ID Numbers:

TDFAV

First Posted:

Jul 27, 2018

Last Update Posted:

Jul 31, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Diana Gamal Esmat Fouad Botros, Principle Investigator, Assiut University

acne vulgaris

thyroid dysfunction

Additional relevant MeSH terms:

Acne Vulgaris

Thyroid Diseases

Study Results

No Results Posted as of Jul 31, 2018