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Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Primary Purpose

Acne

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Spironolactone
Doxycycline Hyclate
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring spironolactone, doxycycline

Eligibility Criteria

16 Years - 40 Years (Child, Adult)FemaleAccepts 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
  • Treatment with a drospirenone containing combined oral contraceptive
  • Sebacia laser treatment within the past 12 months

Sites / Locations

  • Johnson DermatologyRecruiting
  • University of California San FranciscoRecruiting
  • University of MiamiRecruiting
  • New Horizon Research CenterRecruiting
  • Dawes Fretzin Clinical Research GroupRecruiting
  • Brigham and Women's HospitalRecruiting
  • Ohio State University Medical CenterRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Penn State University (Hershey Medical Center)Recruiting
  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spironolactone

Doxycycline hyclate

Arm 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.

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.

Outcomes

Primary Outcome Measures

Absolute change in inflammatory papules and pustules
Difference in change in inflammatory papules and pustules between those randomized to spironolactone versus doxycycline hyclate

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2020
Last Updated
October 24, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04582383
Brief Title
Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
Official Title
A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
spironolactone, doxycycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spironolactone
Arm Type
Experimental
Arm 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.
Arm Title
Doxycycline hyclate
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
Dispensation of spironolactone according to the arm description.
Intervention Type
Drug
Intervention Name(s)
Doxycycline Hyclate
Intervention Description
Dispensation of doxycycline hyclate according to the arm description.
Primary Outcome Measure Information:
Title
Absolute change in inflammatory papules and pustules
Description
Difference in change in inflammatory papules and pustules between those randomized to spironolactone versus doxycycline hyclate
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Percentage achieving Investigator Global Assessment (IGA) Success (IGA grade of clear or almost clear; grade 0 or 1)
Description
Difference in percentage achieving IGA success between those randomized to spironolactone versus doxycycline hyclate
Time Frame
Baseline to Week 8, and Week 16
Title
Change in comedonal lesions
Description
Difference in change in comedonal lesions between those randomized to spironolactone versus doxycycline hyclate
Time Frame
Baseline to Week 8, and Week 16
Title
Change in Acne-QoL, an acne-specific quality of life measure
Description
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
Title
Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure
Description
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
Title
Patient global assessment
Description
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
Title
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)
Description
Difference between those randomized to spironolactone versus doxycycline hyclate
Time Frame
Baseline to Week 16

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David J Margolis, MD, PhD
Phone
215-662-2590
Email
margo@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John S Barbieri, MD, MBA
Phone
6172645932
Email
jbarbieri@bwh.harvard.edu
Facility Information:
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Johnson, MD
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Abuabara, MD
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonette Keri, MD
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lazaro Nunez, MD
Facility Name
Dawes Fretzin Clinical Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Fretzin, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Barbieri, MD, MBA
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Kaffenberger, MD
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teri Greiling, MD, PhD
Facility Name
Penn State University (Hershey Medical Center)
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joslyn Kirby, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
45209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Margolis, MD, PhD
First Name & Middle Initial & Last Name & Degree
David Margolis, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available to research teams within 1 year following study completion.
IPD Sharing Time Frame
1 year following study completion

Learn more about this trial

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

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