Topical Androgen Receptor Inhibitor for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in number of papules/pustules
研究概览
简要总结
Mechanism-based acne treatment for transgender patients receiving testosterone currently does not exist and is an unmet medical need. This study explores clascoterone to treat testosterone induced acne. Many treatments we use to treat acne in females cannot be used in transgender males because they interfere with hormone therapy. Androgens have been associated with the development of acne vulgaris. Recently, a topical androgen receptor inhibitor cream (clascoterone) has been FDA-approved for the treatment of acne. However, clinical trials of clascoterone have excluded participants on exogenous hormones. Clascoterone has been hypothesized to be effective in the treatment of acne in transgender male participants on masculinizing hormone therapy, but it has never been studied or reported in the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Masking will occur by the investigational pharmacy.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •transgender male or gender diverse patient on MHT
- •on a stable dose of MHT for at least 3 months prior to the study
- •anticipate being on the same dose of MHT for the duration of the study
- •have steroid-related acne vulgaris as determined by the investigator with onset or worsening after initiation of MHT
- •have at least 20 papules or pustules on the face
- •consistent skin care regimen (topical and systemic medications) for at least 4 weeks prior to enrollment and continue it for the duration of the study (however, note exclusion below that topical steroids on face not allowed for 4 weeks prior to enrollment and during study)*;
- •age 16 years old or older
- •potential participants who have ovaries and are or planning to be sexually active with partners that produce sperm will need to use a medically reliable form of birth control (including but not limited to condoms, intrauterine device, oral contraceptives) before enrollment and during the study
- •Note inhaled steroids are allowed as long as regimen is stable one month prior to enrollment and during the study
排除标准
- •changes in topical or systemic anti-acne medications or procedures within four weeks of study enrollment
- •use of topical steroids on the face within 4 weeks prior to enrollment and during study
- •pregnant or breast-feeding patients
- •unable to provide informed consent, follow the protocol, attend study visits, or any other circumstance or condition which the investigator deems may obscure interpretation of results or affect safety of the potential participant.
研究组 & 干预措施
Clascoterone
干预措施: Clascoterone 1% Top Cream (Drug)
Vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
Change in number of papules/pustules
时间窗: Week 0, and week 12
Total count of papules (including pustules) will be measured on the entire face at screening and monthly during the three month treatment period. Change in total papules count will be used to compare the efficacy of clascoterone 1% cream versus vehicle at time point week 12 versus week 0.
次要结局
- Change in serum testosterone(Week 0, and week 12)
- Change in sebum output(Week 0, and week 12)
- Change in Acne-QoL and AI-ADL scores(Week 0, and week 12)
- Change in microbiomic profile (measured by relative species abundance)(Week 0, and week 12)
研究者
Anne Chang
Professor of Dermatology
Stanford University