Clinical trial NCT03879369: Sexual Dysfunction in Female Patients With Adult Acne Vulgaris
Official title: Sexual Dysfunction in Female Patients With Adult Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acne Vulgaris
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult female patients with acne vulgaris between 18-40 years old and control group of matched age and sex

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of sexual function using FSFI questionnaire
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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