Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04582383
Collaborator
(none)
400
5
2
52
80
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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.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 :
Mar 30, 2022
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Absolute change in inflammatory papules and pustules [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) [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 [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 [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 [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 [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) [Baseline to Week 16]

    Difference between those randomized to spironolactone versus doxycycline hyclate

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johnson Dermatology Fort Smith Arkansas United States 72916
2 University of California San Francisco San Francisco California United States 94115
3 University of Miami Miami Florida United States 33136
4 Penn State University (Hershey Medical Center) Hershey Pennsylvania United States 17033
5 University of Pennsylvania Philadelphia Pennsylvania United States 45209

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04582383
Other Study ID Numbers:
  • R34AR074733-01A1
First Posted:
Oct 9, 2020
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022