- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07822360
Prevalence of Polyendocrine Metabolic Ovarian Syndrome in Patients Diagnosed With Acne Vulgaris in Sohag University Hospital
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Omar Shazly Saleh, Resident
- Phone Number: +201004861933
- Email: oshazly399@gmail.com
Study Locations
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Sohag, Egypt, 82511
- Recruiting
- Sohag University Hospital
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Contact:
- Omar Shazly Saleh, Resident
- Phone Number: +201004861933
- Email: oshazly399@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients diagnosed with acne vulgaris
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Prevalence of polyendocrine metabolic ovarian syndrome (PMOS) among patients diagnosed with acne vulgaris in Sohag university hospital
Time Frame: Over 1 year
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Over 1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- Pourhoseingholi MA, Vahedi M, Rahimzadeh M. Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench. 2013 Winter;6(1):14-7.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Oge' LK, Broussard A, Marshall MD. Acne Vulgaris: Diagnosis and Treatment. Am Fam Physician. 2019 Oct 15;100(8):475-484.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-8-8MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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