Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne (SD-ACNE)

University of Pennsylvania

Status and phase: Active, not recruiting; Phase 4

Conditions: Acne

Treatments: Drug: Spironolactone; Drug: Doxycycline Hyclate

Study type: Interventional

Funder types: Other

Identifiers

NCT04582383

R34AR074733-01A1

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 2 patient groups

Spironolactone

Experimental group

Description:

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.

Treatment:

Drug: Spironolactone

Doxycycline hyclate

Active Comparator group

Description:

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:

Drug: Doxycycline Hyclate