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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03602534
Other study ID # TDFAV
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2018
Est. completion date December 2019

Study information

Verified date July 2018
Source Assiut University
Contact Emad Taha
Phone 01006462294
Email emadtaha76@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 79
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt DGamal Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

Benjamin RW, Calikoglu AS. Hyperthyroidism and lupus-like syndrome in an adolescent treated with minocycline for acne vulgaris. Pediatr Dermatol. 2007 May-Jun;24(3):246-9. — View Citation

Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149. Review. — View Citation

Contreras-Jurado C, Lorz C, García-Serrano L, Paramio JM, Aranda A. Thyroid hormone signaling controls hair follicle stem cell function. Mol Biol Cell. 2015 Apr 1;26(7):1263-72. doi: 10.1091/mbc.E14-07-1251. Epub 2015 Feb 5. — View Citation

Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. — View Citation

Ekiz O, Balta I, Unlu E, Bulbul Sen B, Rifaioglu EN, Dogramaci AC. Assessment of thyroid function and lipid profile in patients with postadolescent acne in a Mediterranean population from Turkey. Int J Dermatol. 2015 Dec;54(12):1376-81. doi: 10.1111/ijd.12547. Epub 2015 Mar 13. — View Citation

Shuster S, Thody AJ. The control and measurement of sebum secretion. J Invest Dermatol. 1974 Mar;62(3):172-90. Review. — View Citation

Stewart TJ, Bazergy C. Thyroid autoimmunity in female post-adolescent acne: A case-control study. Dermatoendocrinol. 2017 Dec 12;9(1):e1405198. doi: 10.1080/19381980.2017.1405198. eCollection 2017. — View Citation

Thomson DB, Grammes CF, Starkey RH, Monsaert RP, Sunderlin FS. Thyroid abnormalities in patients previously treated with irradiation for acne vulgaris. South Med J. 1984 Jan;77(1):21-3. — View Citation

Uyar B, Solak A, Saklamaz A, Akyildiz M, Genc B, Gökduman A. Effects of isotretinoin on the thyroid gland and thyroid function tests in acne patients: A preliminary study. Indian J Dermatol Venereol Leprol. 2016 Sep-Oct;82(5):587-8. doi: 10.4103/0378-6323.182794. — View Citation

Vergou T, Mantzou E, Tseke P, Moustou AE, Katsambas A, Alevizaki M, Antoniou C. Association of thyroid autoimmunity with acne in adult women. J Eur Acad Dermatol Venereol. 2012 Apr;26(4):413-6. doi: 10.1111/j.1468-3083.2011.04084.x. Epub 2011 Apr 27. — View Citation

Zouboulis CC. [Acne vulgaris. The role of hormones]. Hautarzt. 2010 Feb;61(2):107-8, 110-4. doi: 10.1007/s00105-009-1830-1. German. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary thyroid hormone level in female acne vulgaris patients Peripheral blood samples will be taken , for measurement of thyroid hormone by ELISA 1 hour
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