Clinical trial NCT04582383: Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
Official title: A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acne
Keywords: spironolactone
doxycycline
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 350
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute change in inflammatory papules and pustules
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage achieving Investigator Global Assessment (IGA) Success (IGA grade of clear or almost clear; grade 0 or 1)
timeFrame: Baseline to Week 8, and Week 16
measure: Change in comedonal lesions
timeFrame: Baseline to Week 8, and Week 16
measure: Change in Acne-QoL, an acne-specific quality of life measure
timeFrame: Baseline to Week4, Week 8, Week 12, and Week 16
measure: Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure
timeFrame: Baseline to Week4, Week 8, Week 12, and Week 16
measure: Patient global assessment
timeFrame: Baseline to Week4, Week 8, Week 12, and Week 16
measure: 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)
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Sherman Oaks
country: United States
facility: Cura Clinical Research
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: N. New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Cincinnati
country: United States
facility: Dermatologists of Central States
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: CCS Texas
state: Texas
Study officials:
References: