Topical Minocycline Foam for Treatment of Confluent and Reticulated Papillomatosis (CARP)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 35
- 主要终点
- Change in analog score based on blinded reviewer analysis of individuals treated with both daily topical AMZEEQ® (minocycline) compared to topical emollient
研究概览
简要总结
This proof-of-concept trial evaluates the efficacy, safety, and patient satisfaction of topical minocycline foam (AMZEEQ®) in patients aged 9 and older with confluent and reticulated papillomatosis (CARP). Participants will apply AMZEEQ® to one side of the body and a topical emollient to the other for 5 weeks, followed by an optional extension period. The study aims to assess whether topical minocycline is a well-tolerated and effective alternative to oral antibiotics.
详细描述
Confluent and reticulated papillomatosis (CARP) is a dermatologic condition consisting of primarily truncal hyperpigmented and hyperkeratotic papules and macules in adolescents. The exact cause is unclear, though a gram-positive actinomycete, Dietzia papillomatosis, likely plays a role. Resolution of the rash could take a year or even years to fully occur. While the gold-standard is to treat with oral minocycline (100 mg daily), preliminary data suggests that topical minocycline may be effective as well. A case report of a 51-year-old female documents clearance with topical minocycline foam. Other antibiotics can be considered as well, such as azithromycin and erythromycin. Antifungal medications can also be considered as well as topicals such as tretinoin, tacrolimus, and urea.
Oral minocycline has a number of side effects and cannot be used in pregnancy. Given side effects and risks of lengthy oral antibiotic treatment, investigators believe that utilization of topical minocycline foam could be a suitable option for patients, especially those who do not want to be treated with oral minocycline for an extended period of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 9 years
- •Clinical diagnosis of CARP
排除标准
- •Current or recent (within 6 months) use of oral minocycline
- •Pregnancy or breastfeeding
- •History of intracranial hypertension, autoimmune disorder, liver/kidney disease
- •Immunocompromised status
- •Hypersensitivity to tetracyclines
- •Unstable medical condition
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
Experimental Half of the Body
Participants will apply the investigational topical medication to one half of the body that they choose
干预措施: Topical Minocycline Foam FXFM244 (Drug)
Control Half of the Body
Participants apply the control topical emollient without active ingredient to the contralateral half of the body
干预措施: Control (Other)
结局指标
主要结局
Change in analog score based on blinded reviewer analysis of individuals treated with both daily topical AMZEEQ® (minocycline) compared to topical emollient
时间窗: 5 +/- 1 weeks
Comparison between the efficacy of topical minocycline foam and the control emollient. This will be completed by a dermatologist or dermatology resident that will be blinded to which side was treated with which intervention. Assessment will be completed through a visual analog used by the assessor where REDCap will assign a numeric value based on the position of the marking. The blinded photo reviewer will be informed whether the photo is a baseline or follow-up photo, but will be blinded to which side of the body was treatment or control. The photos will be marked to indicate the side of the body, and the photo reviewer will be asked to compare the left baseline side to the left follow-up side, and similarly the right baseline to the right follow-up, using a visual sliding analogue scale, where REDCap will assign a numeric value based on the position of the marking indicator. Average response to treatment among all patients will be determined.
次要结局
- Assess possible adverse effects secondary to topical minocycline (AMZEEQ) use(6 +/- 1 weeks)
- Discern patient satisfaction with daily topical minocycline (AMZEEQ) use compared to daily topical emollient(6 +/- 1 weeks)
研究者
Lara Wine Lee
Professor-Faculty
Medical University of South Carolina