Sexual Dysfunction in Female Patients With Adult Acne Vulgaris

March 14, 2019 updated by: Asmaa A Ghallab, Assiut University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sexual function using FSFI questionnaire
Time Frame: 30 minutes
Summation of the mean score of the six domains of the FSFI questionnaire
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2019

Primary Completion (ANTICIPATED)

May 1, 2020

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (ACTUAL)

March 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST ACNE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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