De Novo Lipogenesis of Sebaceous Glands in Acne
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Sebumeter measurement differences before and after treatment with isotretinoin
研究概览
简要总结
There are two purposes of this study:
- First, the investigators want to see what the differences are in de novo sebaceous lipid production of people with and without acne.
- Secondly, the investigators want to know what happens to sebaceous gland de novo lipid production before and after treatment with topical tretinoin and oral isotretinoin.
详细描述
The primary objective of this study is to understand how de novo lipid production of sebaceous glands are altered in acne and with acne directed therapy.
Hypothesis 1: The overall de novo lipogenesis will be increased in those with acne
Hypothesis 2: Treatment with topical tretinoin and systemic isotretinoin will reduce de novo lipogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 15 to 45 years of age
- •Subject/Parents/Legal Guardian be able to read and comprehend study procedure and consent forms
- •Have acne that is diagnosed by a board certified dermatologist
- •Meet one of the following criteria:
- •already been prescribed oral isotretinoin for treatment of acne
- •have already been prescribed a topical retinoid
- •eligible for prescription of topical tretinoin
排除标准
- •Those who have already initiated or completed a course of systemic isotretinoin
- •Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
- •Those who are pregnant in female participants
- •Those who do not fit the inclusion criteria
研究组 & 干预措施
Acne Subjects on Topical Tretinoin Treatment
Subjects with acne before and after topical retinoid therapy
干预措施: Tretinoin (Drug)
Acne Subjects on Systemic Isotretinoin Treatment
Subjects with acne before and after isotretinoin therapy
干预措施: Isotretinoin (Drug)
结局指标
主要结局
Sebumeter measurement differences before and after treatment with isotretinoin
时间窗: 3 months
Change in the fractional contribution of DNL to the total sebum palmitate before and after treatment with isotretinoin at baseline and 3 months after treatment.
时间窗: 3 months
次要结局
- Change in the investigator global assessment of acne(3 months)
- Change in the lesion counts of inflammatory and non-inflammatory lesions.(3 months)
- Change in the global acne grade score(3 months)
- Difference in the fractional contribution of DNL to the sebum total palmitate before and after treatment with a topical retinoid (adapalene, tazarotene, or tretinoin).(3 months)
- Difference in the fractional contribution of de novo lipogenesis (DNL) to the sebum total palmitate between those with and without acne(3 months)