Sexual Dysfunction in Female Patients With Adult Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

Sexual Dysfunction in Female Patients With Adult Acne Vulgaris

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03879369
• Other study ID #: ST ACNE
• Status: Not yet recruiting
• Start date: May 2019
• Est. completion date: June 2020

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessment of sexual dysfunction in adult females with acne vulgaris and its relation to other variables as quality of life, acne severity and hormonal dysfunction.

Description:

Acne vulgaris is a common chronic inflammatory skin disease of pilosebaceous units. It is characterized by formation of comedones, erythematous papules, pustules and less frequently by nodules, deep pustules, or pseudocysts. In some cases, it may be accompanied by scarring. It is the most common dermatological condition affecting adolescents worldwide. It has a prevalence of almost 85% in people aged 12‐24 years . Women have a high prevalence than men, especially after 25 years of age. It affects 12%-22% of women in their adult life.

Several factors are involved in the pathogenesis of the disease including abnormal sebum production, altered follicular keratinization with subsequent follicular plugging and Propionibacterium acnes colonization . Also, endocrine factor or androgens are considered a major factor involved in the pathogenesis of the disease. It probably results from an androgen excess or exacerbated response of the pilosebaceous unit to the normal circulating androgen levels.

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder to affect women in their reproductive years. It is characterized by hyperandrogenism which results in a series of skin changes including hirsutism, acne, seborrhea and androgenetic alopecia.

Acne vulgaris causes profound negative psychological and social effects on the quality of life (QoL) of patients. It has a great impact on appearance which is linked with self-esteem and self-confidence. Factors that influence the psychological impact of acne include perceived sexual attractiveness, relationships with family and friends, judgments of others, stigmatization, stress, and fear of scarring.

Several researches concluded that body image is an important psychological factor in women sexual well-being. Female sexual dysfunction may associate certain dermatologic diseases as a result of its effect on self-esteem and psychological conditions.

Despite acne vulgaris is a common disease in adult females, little is published on its effect on female sexual function. The published studies were concerned with sexual dysfunction in males with acne vulgaris receiving isotretinoin, females with genital acne (acne inversa) or those with frank hormonal disturbances. None of these studies concluded whether female sexual dysfunction is impaired with acne vulgaris as a relation to its effect on psychological wellbeing or due to associated endocrine factors or other disease variables.

The Female Sexual Function Index (FSFI) is a widely used measurement tool to assess female sexual function. Arabic translation of the FSFI (ArFSFI) has been validated and can be used in the Egyptian population. It is reliable and easy to be understood by women and it is as good as the original FSFI in assessing female sexual function.

The dermatology life quality index (DLQI) is another questionnaire that assess the impact of dermatologic diseases on patient psychometry. It was the first dermatology-specific QOl instrument and to date is the most commonly used.

Acne severity of the patients will be evaluated by the global acne grading system (GAGS). The GAGS is an acne grading system developed by Doshi et al. It is a simple, accurate and fast method for the determination of severity of acne. It requires no special equipment and is relatively cost-effective.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• adult female patients with acne vulgaris between 18-40 years old

Exclusion Criteria:

any disease affecting sexual function will be excluded like

• female genital mutilation.

• females with other major medical, endocrine and genital comorbidities or receiving medications that affect sexual function.

• females with frank psychological disturbances.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Diagnostic Test:
• Hormonal assay
LH , FSH and Free testosterone index (FTI) levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (16)

Anis TH, Gheit SA, Saied HS, Al kherbash SA. Arabic translation of Female Sexual Function Index and validation in an Egyptian population. J Sex Med. 2011 Dec;8(12):3370-8. doi: 10.1111/j.1743-6109.2011.02471.x. Epub 2011 Oct 13. — View Citation

Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15. Review. — View Citation

Chernyshov PV, Zouboulis CC, Tomas-Aragones L, Jemec GB, Manolache L, Tzellos T, Sampogna F, Evers AWM, Dessinioti C, Marron SE, Bettoli V, van Cranenburgh OD, Svensson A, Liakou AI, Poot F, Szepietowski JC, Salek MS, Finlay AY. Quality of life measurement in acne. Position Paper of the European Academy of Dermatology and Venereology Task Forces on Quality of Life and Patient Oriented Outcomes and Acne, Rosacea and Hidradenitis Suppurativa. J Eur Acad Dermatol Venereol. 2018 Feb;32(2):194-208. doi: 10.1111/jdv.14585. Epub 2017 Oct 10. Review. — 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

Dreno B, Bagatin E, Blume-Peytavi U, Rocha M, Gollnick H. Female type of adult acne: Physiological and psychological considerations and management. J Dtsch Dermatol Ges. 2018 Oct;16(10):1185-1194. doi: 10.1111/ddg.13664. Epub 2018 Sep 24. Review. — View Citation

El-Hamd MA, Nada EEA, Moustafa MA, Mahboob-Allah RA. Prevalence of acne vulgaris and its impact of the quality of life among secondary school-aged adolescents in Sohag Province, Upper Egypt. J Cosmet Dermatol. 2017 Sep;16(3):370-373. doi: 10.1111/jocd.12328. Epub 2017 Mar 2. — View Citation

Gowri BV, Chandravathi PL, Sindhu PS, Naidu KS. Correlation of Skin Changes with Hormonal Changes in Polycystic Ovarian Syndrome: A Cross-sectional Study Clinical Study. Indian J Dermatol. 2015 Jul-Aug;60(4):419. doi: 10.4103/0019-5154.160505. — View Citation

Hassanin AM, Ismail NN, El Guindi A, Sowailam HA. The emotional burden of chronic skin disease dominates physical factors among women, adversely affecting quality of life and sexual function. J Psychosom Res. 2018 Dec;115:53-57. doi: 10.1016/j.jpsychores.2018.10.011. Epub 2018 Oct 22. — View Citation

Healy D, Le Noury J, Mangin D. Enduring sexual dysfunction after treatment with antidepressants, 5a-reductase inhibitors and isotretinoin: 300 cases. Int J Risk Saf Med. 2018;29(3-4):125-134. doi: 10.3233/JRS-180744. — View Citation

Hevesi K, Mészáros V, Kövi Z, Márki G, Szabó M. Different Characteristics of the Female Sexual Function Index in a Sample of Sexually Active and Inactive Women. J Sex Med. 2017 Sep;14(9):1133-1141. doi: 10.1016/j.jsxm.2017.07.008. — View Citation

Kurek A, Peters EM, Chanwangpong A, Sabat R, Sterry W, Schneider-Burrus S. Profound disturbances of sexual health in patients with acne inversa. J Am Acad Dermatol. 2012 Sep;67(3):422-8, 428.e1. doi: 10.1016/j.jaad.2011.10.024. Epub 2011 Dec 17. — View Citation

Nasiri Amiri F, Ramezani Tehrani F, Esmailzadeh S, Tohidi M, Azizi F, Basirat Z. Sexual function in women with polycystic ovary syndrome and their hormonal and clinical correlations. Int J Impot Res. 2018 Apr;30(2):54-61. doi: 10.1038/s41443-017-0006-2. Epub 2017 Dec 15. — View Citation

Ragab M, Hassan EM, Elneily D, Fathallah N. Association of interleukin-6 gene promoter polymorphism with acne vulgaris and its severity. Clin Exp Dermatol. 2019 Jan 16. doi: 10.1111/ced.13864. [Epub ahead of print] — View Citation

Rocha MA, Bagatin E. Adult-onset acne: prevalence, impact, and management challenges. Clin Cosmet Investig Dermatol. 2018 Feb 1;11:59-69. doi: 10.2147/CCID.S137794. eCollection 2018. Review. — View Citation

Romanska-Gocka K, Wozniak M, Kaczmarek-Skamira E, Zegarska B. Abnormal plasma lipids profile in women with post-adolescent acne. Postepy Dermatol Alergol. 2018 Dec;35(6):605-608. doi: 10.5114/ada.2018.77612. Epub 2018 Nov 13. — View Citation

Sarhan D, Mohammed GF, Gomaa AH, Eyada MM. Female Genital Dialogues: Female Genital Self-Image, Sexual Dysfunction, and Quality of Life in Patients With Vitiligo With and Without Genital Affection. J Sex Marital Ther. 2016;42(3):267-76. doi: 10.1080/0092623X.2015.1010678. Epub 2015 Feb 4. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sexual function using FSFI questionnaire	Summation of the mean score of the six domains of the FSFI questionnaire	30 minutes