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

NCT03921476 | Withdrawn

• 1 other identifier: BJS07172018
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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

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

Interventions

Online survey OTHER

Online survey completion through Northwestern's REDCap

Subjects on oral antibiotics for a diagnosis of acne vulgaris; Subjects on spironolactone for a diagnosis of acne vulgaris

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Biologically female subjects
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients who have acne vulgaris being treated with spironolactone or oral antibiotics.

You may qualify if:

• Female subjects between 18 and 65 years of age currently taking spironolactone 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
• AND Subjects able to complete an online survey in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Bethanee Schlosser, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor of Dermatology

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)