Acne VulgarisNCT03879369
Sexual Dysfunction in Female Patients With Adult Acne Vulgaris
An observational study of Acne Vulgaris, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Hormonal assay
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: adult female patients with acne vulgaris between 18-40 years old and control group of matched age and sex
Who may be able to join
- adult female patients with acne vulgaris between 18-40 years old
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Hormonal assay
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal assayDiagnostic test
LH , FSH and Free testosterone index (FTI) levels
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sexual function using FSFI questionnaire
Summation of the mean score of the six domains of the FSFI questionnaire
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa A Ghallab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879369
- Sponsor's protocol ID
- ST ACNE
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 18 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28256050Rocha 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.
PubMed 29440921Ragab M, Hassan EM, Elneily D, Fathallah N. Association of interleukin-6 gene promoter polymorphism with acne vulgaris and its severity. Clin Exp Dermatol. 2019 Aug;44(6):637-642. doi: 10.1111/ced.13864. Epub 2019 Jan 16.
PubMed 30652337Romanska-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.
PubMed 30618529Nasiri 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.
PubMed 29242633Gowri 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.
PubMed 26288423Chernyshov 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.
PubMed 28898474Dreno 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.
PubMed 30248242Sarhan 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.
PubMed 25650731Hassanin 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.
PubMed 30470317Healy D, Le Noury J, Mangin D. Enduring sexual dysfunction after treatment with antidepressants, 5alpha-reductase inhibitors and isotretinoin: 300 cases. Int J Risk Saf Med. 2018;29(3-4):125-134. doi: 10.3233/JRS-180744.
PubMed 29733030Kurek 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.
PubMed 22182915Hevesi K, Meszaros V, Kovi Z, Marki G, Szabo 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.
PubMed 28859872Anis 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.
PubMed 21995610Basra 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.
PubMed 18795920
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction in Female Patients With Adult Acne Vulgaris
- ClinicalTrials.gov ID
- NCT03879369
- Acronym / sponsor ID
- ST ACNE
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adult female patients with acne vulgaris between 18-40 years old and control group of matched age and sex
Key inclusion criteria (1 listed)
- adult female patients with acne vulgaris between 18-40 years old
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormonal assayLH , FSH and Free testosterone index (FTI) levels | Diagnostic test | – |
Primary outcome
Evaluation of sexual function using FSFI questionnaire
Time frame: 30 minutes
Summation of the mean score of the six domains of the FSFI questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Background: PubMed 28256050El-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.
- Background: PubMed 29440921Rocha 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.
- Background: PubMed 30652337Ragab M, Hassan EM, Elneily D, Fathallah N. Association of interleukin-6 gene promoter polymorphism with acne vulgaris and its severity. Clin Exp Dermatol. 2019 Aug;44(6):637-642. doi: 10.1111/ced.13864. Epub 2019 Jan 16.
- Background: PubMed 30618529Romanska-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.
- Background: PubMed 29242633Nasiri 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.
- Background: PubMed 26288423Gowri 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.
- Background: PubMed 28898474Chernyshov 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.
- Background: PubMed 30248242Dreno 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.
- Background: PubMed 25650731Sarhan 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.
- Background: PubMed 30470317Hassanin 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.
- Background: PubMed 29733030Healy D, Le Noury J, Mangin D. Enduring sexual dysfunction after treatment with antidepressants, 5alpha-reductase inhibitors and isotretinoin: 300 cases. Int J Risk Saf Med. 2018;29(3-4):125-134. doi: 10.3233/JRS-180744.
- Background: PubMed 22182915Kurek 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.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sexual function using FSFI questionnaire (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879369, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.