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Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

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ClinicalTrials.gov Identifier: NCT04582383
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Acne Drug: Spironolactone Drug: Doxycycline Hyclate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 200 participants will be randomized to treatment with spironolactone 100mg/day and 200 participants will be randomized to treatment with doxycycline hyclate 100mg/day.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
Actual Study Start Date : March 30, 2022
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Spironolactone
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.
Drug: Spironolactone
Dispensation of spironolactone according to the arm description.

Active Comparator: Doxycycline hyclate
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.
Drug: Doxycycline Hyclate
Dispensation of doxycycline hyclate according to the arm description.




Primary Outcome Measures :
  1. Absolute change in inflammatory papules and pustules [ Time Frame: Baseline to Week 16 ]
    Difference in change in inflammatory papules and pustules between those randomized to spironolactone versus doxycycline hyclate


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • Treatment with a drospirenone containing combined oral contraceptive
  • Sebacia laser treatment within the past 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582383


Contacts
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Contact: David J Margolis, MD, PhD 215-662-2590 margo@pennmedicine.upenn.edu
Contact: John S Barbieri, MD, MBA 6172645932 jbarbieri@bwh.harvard.edu

Locations
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United States, Arkansas
Johnson Dermatology Recruiting
Fort Smith, Arkansas, United States, 72916
Contact: Sandra Johnson, MD         
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Katrina Abuabara, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Jonette Keri, MD         
New Horizon Research Center Recruiting
Miami, Florida, United States, 33165
Contact: Lazaro Nunez, MD         
United States, Indiana
Dawes Fretzin Clinical Research Group Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Scott Fretzin, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: John Barbieri, MD, MBA         
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: Benjamin Kaffenberger, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Teri Greiling, MD, PhD         
United States, Pennsylvania
Penn State University (Hershey Medical Center) Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Joslyn Kirby, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 45209
Contact: David Margolis, MD, PhD         
Principal Investigator: David Margolis, MD, PhD         
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04582383    
Other Study ID Numbers: R34AR074733-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available to research teams within 1 year following study completion.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 1 year following study completion

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Pennsylvania:
spironolactone
doxycycline
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Spironolactone
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents