A randomized, double-blind, multi-center comparative effectiveness study of spironolactone versus doxycycline hyclate for the treatment of acne in women

Active Cooperative Agreement Awarded Last action

Award ID
U01AR079752
Recipient
Awarding agency
Obligated
$6,745,582

Award facts

Completion date 87% complete
Originally
Funding
  • $5,705,114.00 Federal
  • $1,040,468.00 Non-federal
Place of performance
Philadelphia, PA 19104, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Acne is one of the most common diseases worldwide, affecting 85% of adolescents and often persisting into adulthood. Acne is responsible for a greater global burden of disease than psoriasis, cellulitis, and melanoma. Although mild acne can usually be managed with topical medications, moderate to severe acne often requires treatment with systemic medications such as oral antibiotics, spironolactone, and isotretinoin. While these medications are a standard part of care, there are very few randomized clinical trials showing efficacy and none that show comparative effectiveness between these commonly used treatment options. The institute of medicine has identified this area as one of the top priorities for comparative effectiveness research. In addition, little is known about the effects of these different treatments on the microbiome. Previous work by our group has shown oral antibiotics are the most common systemic medication used in the treatment of acne and patients frequently use them for more than one year. In fact, dermatologists prescribe more antibiotics per capita than any other specialty. However, prolonged antibiotic use may be associated with a variety of adverse outcomes including bacterial antibiotic resistance, pharyngitis, collagen vascular illnesses, inflammatory bowel disease, and breast and colon cancer. As a result, there is growing international interest and attention specifically from the centers for disease control regarding improving antibiotic stewardship in the outpatient setting and multiple clinical guidelines for acne have recommended reducing the use of antibiotics through the use of non-antimicrobial therapies and by limiting the duration of therapy. For women with moderate to severe acne, spironolactone may represent an effective, well-tolerated therapeutic alternative to oral antibiotics. Originally developed as a potassium-sparing diuretic, for many years IT has also been used off-label for acne due to its potential impact on hormonal pathogenesis of this disease. However, despite expert opinion supporting the use of spironolactone in the treatment of acne, its use remains relatively uncommon and clinical evidence demonstrating the effectiveness of spironolactone is limited to small, often retrospective studies. Trials comparing the effectiveness of spironolactone to that of other medications such as oral antibiotics are lacking. In specific aim 1, we will conduct a double-blind randomized controlled non-inferiority comparative effectiveness study of spironolactone versus doxycycline for women with acne. Since oral tetracycline-class antibiotics like doxycycline are currently the most common systemic medication prescribed for acne, the results of this trial will have substantial implications for the treatment of acne. In specific aim 2, we will evaluate the impact of spironolactone versus doxycycline treatment on the microbiome, which will provide valuable insights regarding the relative effects of antibiotic (doxycycline) versus non-antibiotic (spironolactone) acne treatments on the microbiome. This trial will significantly influence healthcare practice with respect to the treatment of moderate to severe acne in women and inform policy regarding more appropriate use of antibiotics throughout medicine.

Transactions

Action Federal Non-federal Date
Amendment $681,600 $0
Amendment $883,902 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $1,029,338 $0
Amendment $1,029,338 $0
Amendment $1,040,468 $0
Original award $1,040,468 $1,040,468

Subawards

Subrecipient Amount Awarded
Brigham & Womens Hospital Inc. "Dr. Barbieri will assist with the development and implementation of the proposed U01 trial, including participation in weekly to monthly meetings with other… $71,942
University Of Miami Jonette Keri will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $7,575
Johnson Dermatology Sandra Johnson will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $13,560
Subrecipient not on record (See Attached) $6,781
Subrecipient not on record Michael Lin will serve as the Site Principal Investigator. They will employ their best efforts in the performance of the work requirements listed below and… $12,106
Brigham & Womens Hospital Inc. Dr. Barbieri will assist with the development and implementation of the proposed U01 trial, including participation in weekly to monthly meetings with other… $81,730
Johnson Dermatology Sandra Johnson will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $13,560
Subrecipient not on record (See Attached) $12,106
Dermatologists Of Southwestern Ohio, LLC Sandra Johnson will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $6,780
Oregon Health & Science University Teri Greiling will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $13,055
The Feinstein Institutes For Medical Research Ankuri Desai will serve as the Site Principal Investigator. She will employ his/her best efforts in the performance of the work requirements listed below and… $6,924
The Regents Of The University Of California. San Francisco Katrina Abuabara will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $3,188
The Ohio State University Benjamin Kaffenberger will serve as the Site Principal Investigator. He will employ her best efforts in the performance of the work requirements listed below… $15,540
Brigham & Womens Hospital Inc. John Barbieri will serve as the Site Principal Investigator. He will employ her best efforts in the performance of the work requirements listed below and… $17,660
Oregon Health & Science University Teri Greiling will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $6,528
Johnson Dermatology Sandra Johnson will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $27,120
Subrecipient not on record Michael Lin will serve as the Site Principal Investigator. They will employ their best efforts in the performance of the work requirements listed below and… $5,324
Oregon Health & Science University Teri Greiling will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $13,055
The Ohio State University Benjamin Kaffenberger will serve as the Site Principal Investigator. He will employ her best efforts in the performance of the work requirements listed below… $7,770
Johnson Dermatology Sandra Johnson will serve as the Site Principal Investigator. She will employ her best efforts in the performance of the work requirements listed below and… $13,560
Show all 20

Quick answers

Who received award U01AR079752?

U01AR079752 was awarded to The Trustees Of The University Of Pennsylvania by National Insititue of Arthritis and Musculoskeletal and Skin Diseases (National Institutes of Health) on August 17, 2021.

How much is award U01AR079752 worth?

$6,745,582 has been obligated on U01AR079752: $5,705,114 in federal funding and $1,040,468 in non-federal funding.

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