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Sexual Dysfunction in Female Patients With Adult Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03879369
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa A Ghallab, Assiut University

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.

Condition or disease Intervention/treatment
Acne Vulgaris Diagnostic Test: Hormonal assay

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Other
Official Title: Sexual Dysfunction in Female Patients With Adult Acne Vulgaris
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne


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


Primary Outcome Measures :
  1. Evaluation of sexual function using FSFI questionnaire [ Time Frame: 30 minutes ]
    Summation of the mean score of the six domains of the FSFI questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   adult female patients with acne vulgaris between 18-40 years old and control group of matched age and sex
Accepts Healthy Volunteers:   Yes
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
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.
Publications:

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Responsible Party: Asmaa A Ghallab, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03879369    
Other Study ID Numbers: ST ACNE
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases