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Anti-bacterial
Spironolactone vs Doxycycline for Acne
Phase 4
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female sex assigned at birth
Age 16-40 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week4, week 8, week 12, and week 16
Awards & highlights
Study Summary
This trial is comparing the effectiveness of spironolactone versus doxycycline hyclate for women with acne.
Who is the study for?
This trial is for women aged 16-40 with moderate to severe acne, not pregnant or planning pregnancy. Participants must have at least 10 inflamed pimples and a certain severity score on an acne scale. Excluded are those with allergies to tetracycline antibiotics, heart/liver/renal disease, history of high potassium levels, recent use of specific acne treatments or drugs that interact with the trial medications.Check my eligibility
What is being tested?
The study compares Spironolactone (a hormonal therapy) against Doxycycline Hyclate (an antibiotic) in treating women's acne. It aims to see which treatment is more effective while potentially reducing long-term antibiotic use by addressing hormonal factors influencing sebum production.See study design
What are the potential side effects?
Spironolactone may cause menstrual irregularities, breast tenderness, fatigue, and increase potassium levels leading to heart issues. Doxycycline can lead to sun sensitivity, digestive upset like nausea or diarrhea, and rarely causes allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was assigned female at birth.
Select...
I am between 16 and 40 years old.
Select...
I have acne with at least 10 red bumps and a moderate severity score.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week4, week 8, week 12, and week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week4, week 8, week 12, and week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute change in inflammatory papules and pustules
Secondary outcome measures
Change in Acne-QoL, an acne-specific quality of life measure
Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure
Change in comedonal lesions
+3 moreSide effects data
From 2022 Phase 4 trial • 79 Patients • NCT021690898%
Hypotension
5%
Hyperkalemia
5%
Diabetes related
5%
Infection
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
3%
Surgical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SpironolactoneExperimental Treatment1 Intervention
In this arm, participants will receive spironolactone 100mg/day for the entirety of the study. To maximize the generalizability of the study, participants will be allowed to continue their current topical regimen as long as no changes were made in the 4 weeks prior to randomization. No additions to their topical regimen may be made during the study period.
Group II: Doxycycline hyclateActive Control1 Intervention
This arm is an active-comparator arm in which participants will receive doxycycline hyclate 100mg/day for the entirety of the study. To maximize the generalizability of the study, participants will be allowed to continue their current topical regimen as long as no changes were made in the 4 weeks prior to randomization. No additions to their topical regimen may be made during the study period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
2005
Completed Phase 4
~7340
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,002 Previous Clinical Trials
42,880,599 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney disease.I have had Sebacia laser treatment in the last year.I am not taking medications that could react badly with spironolactone or doxycycline.I have not taken isotretinoin in the last 3 months.I was assigned female at birth.I am between 16 and 40 years old.I have acne with at least 10 red bumps and a moderate severity score.You are allergic to antibiotics in the tetracycline family.I have a heart condition.I have a liver condition.You have had high levels of potassium in your blood in the past.I have Addison's disease.I haven't had certain skin treatments in the last 4 weeks.I experience significant drops in blood pressure when standing up.You are allergic to spironolactone.
Research Study Groups:
This trial has the following groups:- Group 1: Doxycycline hyclate
- Group 2: Spironolactone
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Acne Patient Testimony for trial: Trial Name: NCT04582383 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment of volunteers still open for this experiment?
"The records found on clinicaltrials.gov suggest that this trial is actively seeking volunteers and was originally published on March 30th 2022 with a recent update as of October 24th, 2022."
Answered by AI
What evidence has been acquired to suggest Spironolactone's efficacy?
"Spironolactone, which was initially investigated in 2010 at two Ugandan health centres, has now been the focus of 249 completed trials. Moreover, 65 research studies are currently active with a concentration of these investigations taking place around Miami Florida."
Answered by AI
Are seniors excluded from participation in this research?
"This trial is restricted to individuals aged 16-40. Alternatively, 33 trials are available for applicants younger than 16 and 68 studies are offered for seniors older than 65 years old."
Answered by AI
What clinical conditions has Spironolactone been found to ameliorate?
"Primarily used to treat severe acne, spironolactone can also be prescribed to relieve symptoms of illness, trachoma and klebsiella infections."
Answered by AI
May I become a volunteer for this trial?
"The criteria for joining this study are having acne and being between 16 to 40 years old. 400 people will gain admittance into the trial overall."
Answered by AI
What is the current number of medical facilities running this experiment?
"Presently, 10 medical centres are looking for participants to join this trial. These sites span from Miami to Indianapolis and Columbus as well as 8 other cities. To reduce the stress of travelling, please select your closest location when enrolling in the study."
Answered by AI
How many subjects have been included in the research project?
"This clinical trial necessitates 400 qualified participants, which can be sourced from multiple locations such as the New Horizon Research Center of Miami and Dawes Fretzin Clinical Research Group in Indianapolis."
Answered by AI
Has Spironolactone been given the seal of approval by the FDA?
"Due to its status as a Phase 4 treatment, spironolactone has been determined to be safe and thus is assigned a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Pennsylvania
New York
Other
How old are they?
18 - 65
What site did they apply to?
University of California San Francisco
Penn State University (Hershey Medical Center)
Dawes Fretzin Clinical Research Group
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
I have acne and would like to get rid of it. I have financial problems and my acne has increased, I don't know if it's due to stress or it's the soap he used, since it's neutral but it doesn't work for me because it's the cheapest.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Does this trial pay? Will the medicine or experiment be sized or applicable?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- Penn State University (Hershey Medical Center): < 24 hours
- New Horizon Research Center: < 24 hours
- Dawes Fretzin Clinical Research Group: < 48 hours
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