← Back to Search

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
Must not have
Sebacia laser treatment within the past 12 months
Treatment with isotretinoin within the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week4, week 8, week 12, and week 16
Awards & highlights

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 below
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had Sebacia laser treatment in the last year.
Select...
I have not taken isotretinoin in the last 3 months.
Select...
I have a heart condition.
Select...
I have Addison's disease.
Select...
I experience significant drops in blood pressure when standing up.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week4, week 8, week 12, and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week4, week 8, week 12, and week 16 for reporting.

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 more

Side effects data

From 2022 Phase 4 trial • 79 Patients • NCT02169089
8%
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Spironolactone, a hormonal modulator, works by blocking androgen receptors and reducing androgen production, which decreases sebum production—a key factor in acne development. This is particularly beneficial for women with hormonally influenced acne. Doxycycline hyclate, an antibiotic, reduces acne by inhibiting bacterial protein synthesis, thereby decreasing the population of acne-causing bacteria and reducing inflammation. Understanding these mechanisms helps patients and doctors choose treatments that target the specific underlying causes of their acne, leading to more effective and personalized care.
[Treatment of acne vulgaris. A comparison of doxycycline versus minocycline].What's new in acne? An analysis of systematic reviews published in 2009-2010.Randomised controlled multiple treatment comparison to provide a cost-effectiveness rationale for the selection of antimicrobial therapy in acne.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,027 Previous Clinical Trials
42,885,311 Total Patients Enrolled

Media Library

Doxycycline Hyclate (Anti-bacterial) Clinical Trial Eligibility Overview. Trial Name: NCT04582383 — Phase 4
Acne Research Study Groups: Doxycycline hyclate, Spironolactone
Acne Clinical Trial 2023: Doxycycline Hyclate Highlights & Side Effects. Trial Name: NCT04582383 — Phase 4
Doxycycline Hyclate (Anti-bacterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04582383 — Phase 4
Acne Patient Testimony for trial: Trial Name: NCT04582383 — Phase 4
~120 spots leftby Jul 2025