Prevalence of Polyendocrine Metabolic Ovarian Syndrome in Patients Diagnosed With Acne Vulgaris in Sohag University Hospital

NCT07822360 — Recruiting, 90 participants, Sohag University

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RegistryNCT07822360
StatusRecruiting
Study typeObservational
Enrollment90 (Estimated)
SponsorSohag University (Other)
ConditionsPolyendocrine Metabolic Ovarian Syndrome, Acne Vulgaris
Datesstart 2026-08-09, primary completion 2027-02-08 (estimated), completion 2027-05-01 (estimated), first posted 2026-09-16, last updated 2026-09-16
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Polyendocrine Metabolic Ovarian Syndrome All trials for Acne Vulgaris

-Summary

The aim of this study is to determine the prevalence of polyendocrine metabolic ovarian syndrome (PMOS) among female patients diagnosed with acne vulgaris in Sohag university hospital

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+Detailed description

A cross-sectional observational study designed to determine the prevalence of polycystic ovary syndrome (PCOS) among patients diagnosed with acne vulgaris attending Sohag University Hospital.

+Arms and interventions

ArmTypeInterventionsDescription
Patients diagnosed with acne vulgaris

+Outcome measures

Primary outcomes

  • Prevalence of polyendocrine metabolic ovarian syndrome (PMOS) among patients diagnosed with acne vulgaris in Sohag university hospital [Over 1 year]

+Eligibility

Sex: Female, ages: 15 Years to 49 Years

Inclusion Criteria:

* Female patients at childbearing age ( 15 - 49 years) (World Health, 2024).
* Patients clinically diagnosed with acne vulgaris.

  • Clinical diagnosis of Acne vulgaris:

  o Presence of comedones (open/black and closed/white), inflammatory lesions (papules, pustules, or nodules), with or without post-acne changes such as hyperpigmentation or scarring (Oge et al., 2019).
* Patients diagnosed with polyendocrine metabolic ovarian syndrome (PMOS) according to the 2023 International Evidence-based Guideline for PCOS diagnosis.
* Diagnostic criteria for PMOS diagnosis in adults : (Forslund et al., 2024).

  * Diagnosis of PMOS will be based on the presence of at least two of the following three criteria after exclusion of other etiologies:

    1\. Ovulatory dysfunction:
    * Irregular menstrual cycles or oligo/anovulation. 2. Clinical and/or biochemical hyperandrogenism:
    * Clinical signs such as hirsutism and/or acne, or biochemical evidence of elevated androgen levels.

      3\. Polycystic ovarian morphology (PCOM):
    * Polycystic ovaries detected by pelvic ultrasound, or elevated anti-Müllerian hormone (AMH) level in adults as an alternative to ultrasound.
  * Most women with PMOS have a combination of hyperandrogenism and irregular cycles, and in these cases there is no need to assess PCOM. In adolescents, both ovulatory dysfunction and hyperandrogenism are mandatory (Forslund et al., 2024).
* Patients willing to participate and provide informed consent.

Exclusion Criteria:

* Pregnant women.
* Lactating mothers
* Women diagnosed with other acneiform lesions
* Women on certain drug treatments like oral contraceptive pills, ovarian stimulating drugs and oral hypoglycemic agents like metformin.
* Patients with incomplete clinical data or who refuse to participate in the study.

+Locations (1)

FacilityCityCountryStatus
Sohag university hospitalSohagEgyptRecruiting

+Publications

  • Zhuang C, Luo X, Wang W, Sun R, Qi M, Yu J. Cardiovascular Risk According to Body Mass Index in Women of Reproductive Age With Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. Front Cardiovasc Med. 2022 Feb 16;9:822079. doi: 10.3389/fcvm.2022.822079. eCollection 2022. PMID 35252398
  • Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances. Biochem Biophys Rep. 2023 Nov 23;36:101578. doi: 10.1016/j.bbrep.2023.101578. eCollection 2023 Dec. PMID 38076662
  • Teede HJ, Khomami MB, Morman R, Laven JSE, Joham AE, Costello MF, Patil M, Rees DA, Berry L, Cree MG, Zhao H, Norman RJ, Dokras A, Piltonen T; Global Name Change Consortium. Polyendocrine metabolic ovarian syndrome, the new name for polycystic ovary syndrome: a multistep global consensus process. Lancet. 2026 Jun 6;407(10545):2329-2339. doi: 10.1016/S0140-6736(26)00717-8. Epub 2026 May 12. PMID 42119588
  • Taieb A, Feryel A. Deciphering the Role of Androgen in the Dermatologic Manifestations of Polycystic Ovary Syndrome Patients: A State-of-the-Art Review. Diagnostics (Basel). 2024 Nov 16;14(22):2578. doi: 10.3390/diagnostics14222578. PMID 39594244
  • Stener-Victorin E, Teede H, Norman RJ, Legro R, Goodarzi MO, Dokras A, Laven J, Hoeger K, Piltonen TT. Polycystic ovary syndrome. Nat Rev Dis Primers. 2024 Apr 18;10(1):27. doi: 10.1038/s41572-024-00511-3. PMID 38637590
  • Ruth KS, Day FR, Tyrrell J, Thompson DJ, Wood AR, Mahajan A, Beaumont RN, Wittemans L, Martin S, Busch AS, Erzurumluoglu AM, Hollis B, O'Mara TA; Endometrial Cancer Association Consortium; McCarthy MI, Langenberg C, Easton DF, Wareham NJ, Burgess S, Murray A, Ong KK, Frayling TM, Perry JRB. Using human genetics to understand the disease impacts of testosterone in men and women. Nat Med. 2020 Feb;26(2):252-258. doi: 10.1038/s41591-020-0751-5. Epub 2020 Feb 10. PMID 32042192
  • Pourhoseingholi MA, Vahedi M, Rahimzadeh M. Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench. 2013 Winter;6(1):14-7. PMID 24834239
  • Pakornphadungsit K, Harnchoowong S, Wattanakrai P. Evaluation of an Acne Severity Grading Self-Assessment System Suitable for the Thai Population - A Pilot Study. Clin Cosmet Investig Dermatol. 2023 Nov 3;16:3171-3179. doi: 10.2147/CCID.S427648. eCollection 2023. PMID 37941850
  • Ollila MM, Hoek A, Piltonen TT. The association between polycystic ovary syndrome and early cardiovascular disease morbidity strengthens. Eur J Endocrinol. 2023 Jul 20;189(1):R4-R5. doi: 10.1093/ejendo/lvad083. No abstract available. PMID 37461221
  • Oge' LK, Broussard A, Marshall MD. Acne Vulgaris: Diagnosis and Treatment. Am Fam Physician. 2019 Oct 15;100(8):475-484. PMID 31613567
  • Liu Q, Tang B, Zhu Z, Kraft P, Deng Q, Stener-Victorin E, Jiang X. A genome-wide cross-trait analysis identifies shared loci and causal relationships of type 2 diabetes and glycaemic traits with polycystic ovary syndrome. Diabetologia. 2022 Sep;65(9):1483-1494. doi: 10.1007/s00125-022-05746-x. Epub 2022 Jun 30. PMID 35771237
  • Hoeger KM, Dokras A, Piltonen T. Update on PCOS: Consequences, Challenges, and Guiding Treatment. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1071-e1083. doi: 10.1210/clinem/dgaa839. PMID 33211867
  • Hazarika N. Acne vulgaris: new evidence in pathogenesis and future modalities of treatment. J Dermatolog Treat. 2021 May;32(3):277-285. doi: 10.1080/09546634.2019.1654075. Epub 2019 Aug 29. PMID 31393195
  • Forslund M, Melin J, Stener-Victorin E, Hirschberg AL, Teede H, Vanky E, Piltonen T. International evidence-based guideline on assessment and management of PCOS-A Nordic perspective. Acta Obstet Gynecol Scand. 2024 Jan;103(1):7-12. doi: 10.1111/aogs.14725. Epub 2023 Nov 20. PMID 37983875
  • 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
  • Conforti C, Giuffrida R, Fadda S, Fai A, Romita P, Zalaudek I, Dianzani C. Topical dermocosmetics and acne vulgaris. Dermatol Ther. 2021 Jan;34(1):e14436. doi: 10.1111/dth.14436. Epub 2020 Nov 15. PMID 33084158
  • Baldwin H, Farberg A, Frey C, Hartman C, Lain E, Meltzer R, Draelos Z. Unmet Needs in the Management of Acne Vulgaris: A Consensus Statement. J Drugs Dermatol. 2023 Jun 1;22(6):582-587. doi: 10.36849/JDD.7587. PMID 37276154
  • Ach T, Guesmi A, Kalboussi M, Ben Abdessalem F, Mraihi E, El Mhabrech H. Validation of the follicular and ovarian thresholds by an 18-MHz ultrasound imaging in polycystic ovary syndrome: a pilot cutoff for North African patients. Ther Adv Reprod Health. 2024 Aug 20;18:26334941241270372. doi: 10.1177/26334941241270372. eCollection 2024 Jan-Dec. PMID 39170801
  • Results publication: BLIEDE, K., ROUMIA, A. H. & KHADDAM, J. 2020. Prevalence of Polycystic Ovary Syndrome in Women with Acne Vulgaris. Asian Journal of Research in Dermatological Science, 3, 5-13.
  • Results publication: JABEEN, S., ASAD, F., RANI, Z., KHURSHID, K. & PAL, S. S. 2018. Frequency of polycystic ovarian syndrome among patients presenting with acne. Journal of Pakistan Association of Dermatologists, 28, 329-332