Acne VulgarisNCT03921476
Acne and Mood: Impact of Treatment on Depression, Anxiety, and Sexual Function
An observational study of Acne Vulgaris, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Online survey
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 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 65 years
- Women only
- Adult, Older adult
Study population: Female patients who have acne vulgaris being treated with spironolactone or oral antibiotics.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Online survey
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online surveyOther
Online survey completion through Northwestern's REDCap
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Online survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: Investigator left Northwestern University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Rangel, Northwestern University
- Investigators
- Bethanee Schlosser, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921476
- Sponsor's protocol ID
- BJS07172018
- Status last verified
- Oct 2020
- First submitted
- 16 Apr 2019
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acne and Mood: Impact of Treatment on Depression, Anxiety, and Sexual Function
- ClinicalTrials.gov ID
- NCT03921476
- Acronym / sponsor ID
- BJS07172018
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator left Northwestern University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Apr 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.
This study seeks to examine if there is any relationship between spironolactone use prescribed for acne vulgaris and depression, anxiety, and/or sexual function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects on spironolactone for a diagnosis of acne vulgaris | – | Other: Online surveyFemale 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 | – | Other: Online surveyFemale subjects between 18 and 65 years of age currently taking oral antibiotics for a diagnosis of acne vulgaris |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female patients who have acne vulgaris being treated with spironolactone or oral antibiotics.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Online surveyOnline survey completion through Northwestern's REDCap | Other | Subjects on oral antibiotics for a diagnosis of acne vulgaris, Subjects on spironolactone for a diagnosis of acne vulgaris |
Primary outcome
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
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
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Bethanee Schlosser, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Northwestern University at 1 site in United States.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent correlation between spironolactone use for acne vulgaris and increased prevalence of depression. (time frame: one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2020.