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Status unknownNCT03602534Updated Jul 31, 2018

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

An observational study in Acne Vulgaris and Thyroid Dysfunction, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
79
Ages
16 Years to 45 Years
Sex
Female
01

Study 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 .

Read the 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.

02

Conditions studied

  • Acne Vulgaris
  • Thyroid Dysfunction

Keywords

  • acne vulgaris
  • thyroid dysfunction
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's planned enrollment of 79 is below the median of 90 across 81 observational studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
79 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and 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

06

What researchers measure

Primary outcomes

  1. thyroid hormone level in female acne vulgaris patients

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

    Time frame: 1 hour

07

Study locations

1 site
08

References and documents

Publications

  • Bhate K, Williams HC. Epidemiology of acne vulgaris. Br J Dermatol. 2013 Mar;168(3):474-85. doi: 10.1111/bjd.12149. PubMed 23210645 ↗
  • 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. PubMed 20107754 ↗
  • 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. PubMed 25657324 ↗
  • 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. PubMed 4361984 ↗
  • 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. PubMed 21521376 ↗
  • 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. PubMed 25771990 ↗
  • 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. PubMed 6229881 ↗
  • 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. PubMed 17542873 ↗
  • 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. PubMed 27212279 ↗
  • 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. PubMed 9248884 ↗
  • 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. PubMed 29484104 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03602534
Lead sponsor
Assiut University
Responsible party
Diana Gamal Esmat Fouad Botros (Principle Investigator, Assiut University) — Principal investigator
First posted
Jul 27, 2018
Start date
Dec 2018 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Jul 31, 2018

Study contacts

Emad Taha
Contact
emadtaha76@yahoo.com
01006462294
Reham Abdel-Gaber
Contact
rehamaher707@yahoo.com
01005043777
Emad Taha
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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