A Randomized, Double-Blind, Multi-Center Comparative Effectiveness Study of Spironolactone Versus Doxycycline Hyclate for the Treatment of Acne in Women
概览
- 阶段
- 4 期
- 干预措施
- Spironolactone
- 疾病 / 适应症
- Acne
- 发起方
- University of Pennsylvania
- 入组人数
- 350
- 试验地点
- 18
- 主要终点
- Absolute change in inflammatory lesion count
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Spironolactone
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.
干预措施: Doxycycline Hyclate
结局指标
主要结局
Absolute change in inflammatory lesion count
时间窗: Baseline to Week 16
Difference in change in inflammatory lesion count between those randomized to spironolactone versus doxycycline hyclate
次要结局
- Change in Dermatology Life Quality Index (DLQI), a dermatology-specific quality of life measure(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)(Baseline to Week 16)
- 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)
- Change in Acne-QoL, an acne-specific quality of life measure(Baseline to Week4, Week 8, Week 12, and Week 16)
- Patient global assessment(Baseline to Week4, Week 8, Week 12, and Week 16)
- Change in comedonal lesions(Baseline to Week 8, and Week 16)