Acne
Conditions
Keywords
spironolactone, doxycycline
Brief 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 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.
Interventions
DRUGSpironolactone
Dispensation of spironolactone according to the arm description.
Dispensation of doxycycline hyclate according to the arm description.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Pregnancy * Heart disease * Renal disease * Liver disease * Orthostatic hypotension * Addison's disease * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change in inflammatory lesion count | Baseline to Week 16 | Difference in change in inflammatory lesion count between those randomized to spironolactone versus doxycycline hyclate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage achieving Investigator Global Assessment (IGA) Success (IGA grade of clear or almost clear; grade 0 or 1) | Baseline to Week 8, and Week 16 | Difference in percentage achieving IGA success between those randomized to spironolactone versus doxycycline hyclate |
| Change in comedonal lesions | Baseline to Week 8, and Week 16 | Difference in change in comedonal lesions between those randomized to spironolactone versus doxycycline hyclate |
| Change in Acne-QoL, an acne-specific quality of life measure | Baseline to Week4, Week 8, Week 12, and Week 16 | 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. |
| Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure | Baseline to Week4, Week 8, Week 12, and Week 16 | 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. |
| Patient global assessment | Baseline to Week4, Week 8, Week 12, and Week 16 | Difference in change in patient global assessment scores between those randomized to spironolactone versus doxycycline hyclate. |
| 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) | Baseline to Week 16 | Difference between those randomized to spironolactone versus doxycycline hyclate |
Countries
United States
Outcome results
None listed