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

NCT03602534 | Unknown

• 1 other identifier: TDFAV
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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 .

Conditions

Acne Vulgaris; Thyroid Dysfunction

Keywords

acne vulgaris; thyroid dysfunction

Outcome Measures

Primary Outcomes (1)

• thyroid hormone level in female acne vulgaris patients

  Peripheral blood samples will be taken , for measurement of thyroid hormone by ELISA

  1 hour

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

DGamal

Asyut, Egypt

Location

Related Publications (11)

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

  PMID: 23210645 BACKGROUND

• 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.

  PMID: 20107754 BACKGROUND

• Contreras-Jurado C, Lorz C, Garcia-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.

  PMID: 25657324 BACKGROUND

• Shuster S, Thody AJ. The control and measurement of sebum secretion. J Invest Dermatol. 1974 Mar;62(3):172-90. doi: 10.1111/1523-1747.ep12676782. No abstract available.

  PMID: 4361984 BACKGROUND

• 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.

  PMID: 21521376 BACKGROUND

• 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.

  PMID: 25771990 BACKGROUND

• 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. doi: 10.1097/00007611-198401000-00007.

  PMID: 6229881 BACKGROUND

• 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. doi: 10.1111/j.1525-1470.2007.00395.x.

  PMID: 17542873 BACKGROUND

• Uyar B, Solak A, Saklamaz A, Akyildiz M, Genc B, Gokduman 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.

  PMID: 27212279 BACKGROUND

• 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. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.

  PMID: 9248884 BACKGROUND

• 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. No abstract available.

  PMID: 29484104 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples (serum)

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Emad Taha

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Emad Taha

CONTACT

01006462294; emadtaha76@yahoo.com

Reham Abdel-Gaber

CONTACT

01005043777; rehamaher707@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

EG (1)