Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04582383

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Johnson Dermatology, Fort Smith, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spironolactone

Drug

Dispensation of spironolactone according to the arm description.

Doxycycline Hyclate

Drug

Dispensation of doxycycline hyclate according to the arm description.

Primary outcomes

  1. Absolute change in inflammatory lesion count

    Time frame: Baseline to Week 16

    Difference in change in inflammatory lesion count between those randomized to spironolactone versus doxycycline hyclate

Secondary outcomes

  1. Percentage achieving Investigator Global Assessment (IGA) Success (IGA grade of clear or almost clear; grade 0 or 1)

    Time frame: Baseline to Week 8, and Week 16

    Difference in percentage achieving IGA success between those randomized to spironolactone versus doxycycline hyclate

  2. Change in comedonal lesions

    Time frame: Baseline to Week 8, and Week 16

    Difference in change in comedonal lesions between those randomized to spironolactone versus doxycycline hyclate

  3. Change in Acne-QoL, an acne-specific quality of life measure

    Time frame: 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.

  4. Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure

    Time frame: 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.

  5. Patient global assessment

    Time frame: 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.

  6. 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)

    Time frame: Baseline to Week 16

    Difference between those randomized to spironolactone versus doxycycline hyclate

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: SD-ACNE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 9, 2020
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.