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NCT03921476 Clinical Trial

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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03921476
Other study ID # BJS07172018
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2020

Study information
Verified date October 2020
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Online survey
Online survey completion through Northwestern's REDCap

Locations
Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

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