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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03921476
Recruitment Status : Withdrawn (Investigator left Northwestern University)
First Posted : April 19, 2019
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Stephanie Rangel, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment
Acne Vulgaris Other: Online survey

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acne and Mood: Impact of Treatment on Depression, Anxiety, and Sexual Function
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Anxiety

Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects on spironolactone for a diagnosis of acne vulgaris
Female subjects between 18 and 65 years of age currently taking spironolactone for a diagnosis of acne vulgaris
 Other: Online survey
Online survey completion through Northwestern's REDCap
Subjects on oral antibiotics for a diagnosis of acne vulgaris
Female subjects between 18 and 65 years of age currently taking oral antibiotics for a diagnosis of acne vulgaris
 Other: Online survey
Online survey completion through Northwestern's REDCap


Outcome Measures
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Primary Outcome Measures :
  1. Percent correlation between spironolactone use for acne vulgaris and increased prevalence of depression. [ Time Frame: one week ]
    Score for depression from subject reported Dermatology Life Quality Index (DLQI) survey

  2. Percent correlation between spironolactone use for acne vulgaris and increased prevalence of anxiety. [ Time Frame: two weeks ]
    Score for depression from subject reported Generalized Anxiety Disorder (GAD-7) survey

  3. Percent correlation between spironolactone use for acne vulgaris and increased prevalence of sexual dysfunction. [ Time Frame: four weeks ]
    Score for depression from subject reported Female Sexual Function Index (FSFI) survey.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Biologically female subjects
Sampling Method:   Non-Probability Sample
Study Population
Female patients who have acne vulgaris being treated with spironolactone or oral antibiotics.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921476


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Bethanee Schlosser, MD Northwestern University
More Information
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Responsible Party: Stephanie Rangel, Research Assistant Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT03921476    
Other Study ID Numbers: BJS07172018
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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