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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | Dispensation of spironolactone according to the arm description. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in inflammatory lesion count | Difference in change in inflammatory lesion count between those randomized to spironolactone versus doxycycline hyclate | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Week 8, and Week 16 |
| Change in comedonal lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson Dermatology | Fort Smith | Arkansas | 72916 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39066638 | Derived | 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. |
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IPD will be available to research teams within 1 year following study completion.
1 year following study completion
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175 participants will be randomized to treatment with spironolactone 100mg/day and 175 participants will be randomized to treatment with doxycycline hyclate 100mg/day.
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| Doxycycline Hyclate |
| Drug |
Dispensation of doxycycline hyclate according to the arm description. |
|
Difference in change in comedonal lesions between those randomized to spironolactone versus doxycycline hyclate |
| 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. | 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. | 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. | 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 | Baseline to Week 16 |
| San Francisco |
| California |
| 94115 |
| United States |
| Cura Clinical Research | Sherman Oaks | California | 92866 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46250 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| New York University | New York | New York | 10016 | United States |
| Northwell Health | North New Hyde Park | New York | 11042 | United States |
| Dermatologists of Central States | Cincinnati | Ohio | 45242 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43215 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 45209 | United States |
| Arlington Research Center | Arlington | Texas | 76011 | United States |
| North Texas Center for Clinical Research | Frisco | Texas | 75034 | United States |
| CCS Texas | Houston | Texas | 77004 | United States |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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