Summary

Eligibility
for females ages 16-40 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
estimated completion

Description

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.

Official Title

A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women

Keywords

Acne spironolactone doxycycline Acne Vulgaris Doxycycline Hyclate

Eligibility

You can join if…

Open to females ages 16-40

  • 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

You CAN'T join if...

  • 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
  • Treatment with a drospirenone containing combined oral contraceptive
  • Sebacia laser treatment within the past 12 months

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • Johnson Dermatology accepting new patients
    Fort Smith Arkansas 72916 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pennsylvania
ID
NCT04582383
Phase
Phase 4 Acne Research Study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated