Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Phase 4Active Not RecruitingNCT04582383

University of Pennsylvania350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

350

Conditions

Acne

Interventions

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (18)

Johnson Dermatology

Fort Smith, Arkansas, United States

University of California San Francisco

San Francisco, California, United States

Cura Clinical Research

Sherman Oaks, California, United States

University of Miami

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

New York University

New York, New York, United States

Northwell Health

North New Hyde Park, New York, United States

Dermatologists of Central States

Cincinnati, Ohio, United States

...and 8 more locations

Outcomes

Primary Outcomes

Absolute change in inflammatory lesion count

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

Time frame: Baseline to Week 16

Secondary Outcomes

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

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

Time frame: Baseline to Week 8, and Week 16

Change in comedonal lesions

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

Time frame: Baseline to Week 8, and Week 16

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

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.

Time frame: Baseline to Week4, Week 8, Week 12, and Week 16

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

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.

Time frame: Baseline to Week4, Week 8, Week 12, and Week 16

Patient global assessment

Difference in change in patient global assessment scores between those randomized to spironolactone versus doxycycline hyclate.

Time frame: Baseline to Week4, Week 8, Week 12, and Week 16

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)

Difference between those randomized to spironolactone versus doxycycline hyclate

Time frame: Baseline to Week 16