AcnePhase 4SD-ACNENCT04582383
Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
A Phase 4 study testing Spironolactone and Doxycycline Hyclate in people with Acne, run by University of Pennsylvania at 18 sites in United States.
Trial summary
Acne is common illness of adolescents and young adults which is associated with substantial morbidity. While topical treatments are often sufficient for mild acne, moderate to severe acne often requires treatment with systemic medications such as oral antibiotics, hormonal therapies such spironolactone, and… Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Spironolactone and Doxycycline Hyclate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Mar 2022to 31 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female sex assigned at birth
- Age 16-40 years old
- Acne defined as at least 10 inflammatory papules or pustules and an Investigator's Global Assessment (IGA) score of at least 2 as measured by the Comprehensive Acne Severity Scale
- Not currently pregnant or planning to become pregnant
Who cannot join
- Pregnancy
- Heart disease
- Renal disease
- Liver disease
- Orthostatic hypotension
- Addison's disease
Show all 13Show fewer
- History of hyperkalemia
- Allergy to tetracycline-class antibiotic
- Allergy to spironolactone
- Concomitant use of medications known to interact with spironolactone or doxycycline or that may increase the risk for hyperkalemia, including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, eplerenone, nonsteroidal anti-inflammatory drugs, and digoxin.
- Treatment with spironolactone, an oral antibiotic, laser, photodynamic therapy, or chemical peel within the past 4 weeks
- Treatment with isotretinoin within the past 3 months
- Sebacia laser treatment within the past 12 months
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Arlington Research Center
Arlington, Texas, 76011
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dermatologists of Central States
Cincinnati, Ohio, 45242
Ohio State University Medical Center
Columbus, Ohio, 43215
Johnson Dermatology
Fort Smith, Arkansas, 72916
North Texas Center for Clinical Research
Frisco, Texas, 75034
Cyn3rgy Research
Gresham, Oregon, 97030
CCS Texas
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46250
University of Miami
Miami, Florida, 33136
New Horizon Research Center
Miami, Florida, 33165
New York University
New York, New York, 10016
Northwell Health
North New Hyde Park, New York, 11042
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 45209
Oregon Health and Science University
Portland, Oregon, 97239
University of California San Francisco
San Francisco, California, 94115
Cura Clinical Research
Sherman Oaks, California, 92866
About this study
Official title: A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
Acne is common illness of adolescents and young adults which is associated with substantial morbidity. While topical treatments are often sufficient for mild acne, moderate to severe acne often requires treatment with systemic medications such as oral antibiotics, hormonal therapies such spironolactone, and isotretinoin. Sebum overproduction is fundamental to the pathogenesis of acne with associated disordered keratinization and subsequent microbial colonization and inflammation resulting in the clinical manifestations of acne. Given the influence of hormones on sebum production, therapies that address these underlying hormonal factors such as spironolactone and oral contraceptive pills represent an underutilized treatment option for women with acne and could help decrease the use of long-term oral antibiotics in this patient population. The purpose of this trial is to evaluate the comparative effectiveness of spironolactone versus doxycycline hyclate (tetracycline class antibiotic) for women with acne.
- Conditions
- Acne
- Being tested
- Spironolactone, Doxycycline Hyclate
- Keywords
- spironolactone, doxycycline
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Dispensation of spironolactone according to the arm description.
Doxycycline HyclateDrug
Dispensation of doxycycline hyclate according to the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Experimental | 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. Receives: Drug: Spironolactone |
| Doxycycline hyclate | Active comparator | 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. Receives: Drug: Doxycycline Hyclate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in inflammatory lesion count
Difference in change in inflammatory lesion count between those randomized to spironolactone versus doxycycline hyclate
Measured: Baseline to Week 16
Secondary outcomes (6)
Percentage achieving Investigator Global Assessment (IGA) Success (IGA grade of clear or almost clear; grade 0 or 1)
Difference in percentage achieving IGA success between those randomized to spironolactone versus doxycycline hyclate
Measured: Baseline to Week 8, and Week 16
Change in comedonal lesions
Difference in change in comedonal lesions between those randomized to spironolactone versus doxycycline hyclate
Measured: Baseline to Week 8, and Week 16
Change in Acne-QoL, an acne-specific quality of life measure
Difference in change in Acne-QoL score between those randomized to spironolactone versus doxycycline hyclate. There are 4 subscales: self perception, scored 0-30; role social, scored 0-24; role-emotional, scored 0-30; and acne symptoms, scored 0-30. Higher scores indicate better quality of life.
Measured: Baseline to Week4, Week 8, Week 12, and Week 16
Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure
Difference in change in DLQI score between those randomized to spironolactone versus doxycycline hyclate. Scores range from 0-30, with lower scores indicated better quality of life.
Measured: Baseline to Week4, Week 8, Week 12, and Week 16
Patient global assessment
Difference in change in patient global assessment scores between those randomized to spironolactone versus doxycycline hyclate.
Measured: Baseline to Week4, Week 8, Week 12, and Week 16
Percentage on any topical medication at baseline who discontinued at least one of these topical medications (i.e. topical retinoid, benzoyl peroxide, and topical antibiotic)
Difference between those randomized to spironolactone versus doxycycline hyclate
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start30 Mar 2022
- Primary completion14 Feb 2026
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 175 participants will be randomized to treatment with spironolactone 100mg/day and 175 participants will be randomized to treatment with doxycycline hyclate 100mg/day.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582383
- Sponsor's protocol ID
- R34AR074733-01A1
- Other IDs
- U01AR079752-01
- Acronym
- SD-ACNE
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2020
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available to research teams within 1 year following study completion.
Publications
Barbieri JS, Ellenberg S, Grice E, Tierney A, VanderBeek SB, Papadopoulos M, Mason J, Mason A, Dattilo J, Margolis DJ. Challenges in designing a randomized, double-blind noninferiority trial for treatment of acne: The SD-ACNE trial. Clin Trials. 2025 Feb;22(1):66-76. doi: 10.1177/17407745241265094. Epub 2024 Jul 27.
PubMed 39066638
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
- ClinicalTrials.gov ID
- NCT04582383
- Acronym / sponsor ID
- SD-ACNE / R34AR074733-01A1
- Conditions
- Acne
- Keywords
- spironolactone, doxycycline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 14 Feb 2026 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Oct 2020 (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.
Acne is common illness of adolescents and young adults which is associated with substantial morbidity. While topical treatments are often sufficient for mild acne, moderate to severe acne often requires treatment with systemic medications such as oral antibiotics, hormonal therapies such spironolactone, and isotretinoin. Sebum overproduction is fundamental to the pathogenesis of acne with associated disordered keratinization and subsequent microbial colonization and inflammation resulting in the clinical manifestations of acne. Given the influence of hormones on sebum production, therapies that address these underlying hormonal factors such as spironolactone and oral contraceptive pills represent an underutilized treatment option for women with acne and could help decrease the use of long-term oral antibiotics in this patient population. The purpose of this trial is to evaluate the comparative effectiveness of spironolactone versus doxycycline hyclate (tetracycline class antibiotic) for women with acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 175 participants will be randomized to treatment with spironolactone 100mg/day and 175 participants will be randomized to treatment with doxycycline hyclate 100mg/day.
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Experimental | Drug: SpironolactoneIn 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. |
| Doxycycline hyclate | Active comparator | Drug: Doxycycline HyclateThis 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. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female sex assigned at birth
- Age 16-40 years old
- Acne defined as at least 10 inflammatory papules or pustules and an Investigator's Global Assessment (IGA) score of at least 2 as measured by the Comprehensive Acne Severity Scale
- Not currently pregnant or planning to become pregnant
Key exclusion criteria (13 listed)
- Pregnancy
- Heart disease
- Renal disease
- Liver disease
- Orthostatic hypotension
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 |
|---|---|---|
| SpironolactoneDispensation of spironolactone according to the arm description. | Drug | Spironolactone |
| Doxycycline HyclateDispensation of doxycycline hyclate according to the arm description. | Drug | Doxycycline hyclate |
Primary outcome
Absolute change in inflammatory lesion count
Time frame: Baseline to Week 16
Difference in change in inflammatory lesion count between those randomized to spironolactone versus doxycycline hyclate
6 secondary outcomes
Percentage achieving Investigator Global Assessment (IGA) Success (IGA grade of clear or almost clear; grade 0 or 1)
Time frame: Baseline to Week 8, and Week 16
Change in comedonal lesions
Time frame: Baseline to Week 8, and Week 16
Change in Acne-QoL, an acne-specific quality of life measure
Time frame: Baseline to Week4, Week 8, Week 12, and Week 16
Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure
Time frame: Baseline to Week4, Week 8, Week 12, and Week 16
Patient global assessment
Time frame: Baseline to Week4, Week 8, Week 12, and Week 16
Percentage on any topical medication at baseline who discontinued at least one of these topical medications (i.e. topical retinoid, benzoyl peroxide, and topical antibiotic)
Time frame: Baseline to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 39066638Barbieri JS, Ellenberg S, Grice E, Tierney A, VanderBeek SB, Papadopoulos M, Mason J, Mason A, Dattilo J, Margolis DJ. Challenges in designing a randomized, double-blind noninferiority trial for treatment of acne: The SD-ACNE trial. Clin Trials. 2025 Feb;22(1):66-76. doi: 10.1177/17407745241265094. Epub 2024 Jul 27.
- Individual participant dataSharing planned: Yes. IPD will be available to research teams within 1 year following study completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone and Doxycycline Hyclate in people with Acne, run by University of Pennsylvania at 18 sites 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 13 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Absolute change in inflammatory lesion count (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04582383, which also lists 1 linked publication.
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 25 Aug 2026.