Acne and Mood: Impact of Treatment on Depression, Anxiety, and Sexual Function

Withdrawn

• Conditions: Acne Vulgaris
• Interventions: Other: Online survey

• Registration Number: NCT03921476
• Lead Sponsor: Northwestern University

Brief Summary

This study seeks to examine if there is any relationship between spironolactone use prescribed for acne vulgaris and depression, anxiety, and/or sexual function.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-19
• Study Start: 2020-07-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Female subjects between 18 and 65 years of age currently taking spironolactone for a diagnosis of acne vulgaris

OR

Female subjects between 18 and 65 years of age currently taking oral antibiotics for a diagnosis of acne vulgaris

AND Subjects able to complete an online survey in English

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Exclusion Criteria

Subjects less than 18 years of age or older than 65 years of age Subjects that have ever been diagnosed with any mood disorder by a clinician prior to starting spironolactone (history of mood disorder or current mood disorder) Subjects taking hormonal contraception (including but not limited to oral contraceptive pills) for a duration of less than 6 months Subjects that have ever been diagnosed with any type of sexual dysfunction prior to starting spironolactone Subjects not able to complete an online survey in English Subjects taking oral isotretinoin for a diagnosis of acne Subjects that are currently pregnant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects on spironolactone for a diagnosis of acne vulgaris	Online survey	Female subjects between 18 and 65 years of age currently taking spironolactone for a diagnosis of acne vulgaris
Subjects on oral antibiotics for a diagnosis of acne vulgaris	Online survey	Female subjects between 18 and 65 years of age currently taking oral antibiotics for a diagnosis of acne vulgaris

Primary Outcome Measures

Name	Time	Method
Percent correlation between spironolactone use for acne vulgaris and increased prevalence of sexual dysfunction.	four weeks	Score for depression from subject reported Female Sexual Function Index (FSFI) survey.
Percent correlation between spironolactone use for acne vulgaris and increased prevalence of depression.	one week	Score for depression from subject reported Dermatology Life Quality Index (DLQI) survey
Percent correlation between spironolactone use for acne vulgaris and increased prevalence of anxiety.	two weeks	Score for depression from subject reported Generalized Anxiety Disorder (GAD-7) survey

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States