A single-blinded prospective study to assess the efficacy of Sulfotransfarase (SULT) enzyme boosters in limited and nonresponding patients of androgenetic alopecia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the efficacy of the SULT enzyme boosters in non-responders and limited responders to minoxidil and evaluate the treatment outcome
研究概览
简要总结
Androgenetic alopecia is a genetically predetermined disorder due to an excessive response to androgens .The incidence approximates the age in Caucasian males, with 50% affected by 50 years old and up to 80% affected by 70 years old.In the Indian context, a prevalence rate of 58% in males aged 30–50 years has been found. In all cases, the incidence gradually increases with age.
Minoxidil , Finasteride, the Hair Max Laser Comb are the only treatment options that is approved by the FDA for androgenetic alopecia. Minoxidil is the only topical drug approved by the US FDA to regrow hair1
Minoxidil is a produrug, a potent arteriolar vasodilator that opens potassium channels located on the smooth muscles of the peripheral artery, causing hyperpolarization of the cell membrane.In order to exert biological activity, minoxidil requires conversion to minoxidil sulfate by sulfotransferase enzymes (SULT1A1). which is located in hair follicles and varies in production among individuals. The patients with higher enzyme activity responded better to topical minoxidil than those with lower enzyme activity.
Hypoxia is difficult to mimic in a therapy; other mechanisms that would affect similar regulatory pathways intersecting hypoxia and sulfotransferase activity. One such mechanism is intercellular pH 2Specifically, increased sulfotransferase is a biomarker for keratinocyte differentiation3To increase the pH of the follicular stem cells as a means of increasing sulfotransferase activity. Hence a novel topical formula has been developed
The formula uses a liposomal encapsulated alkalizing agent to change the pH of the ORS. The encapsulated chemistry increase penetration of the alkalizing agent into the cells.2
In this study we intend to study the efficacy of sulfenzyme booster in increasing the response to topical minoxidil who are not responding or having limited response to minoxidil
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female patients, from 18-45 years of age Androgenetic Alopecia (AGA) patients who had limited or no response to topical minoxidil Participants who are able to provide a written informed consent and photo consent form Participants who are willing to be clinically photographed as per protocol.
排除标准
- •Patient who is not willing to participate in the study.
- •Patients with scalp conditions like seborrheic dermatitis or drugs like low-dose aspirin or topical tretinoin interfering with the treatment response.
结局指标
主要结局
To assess the efficacy of the SULT enzyme boosters in non-responders and limited responders to minoxidil and evaluate the treatment outcome
时间窗: After 3 Months
次要结局
- Global photography assessment will be concerning hair growth at every visit like baseline, week 4, Week 8, and Week 12: scale as follows: -2(moderately worse), -1(slightly worse), 0 (no change), +1 (slightly improved), and +2 (moderately improved).(Trichoscopic assessment done at every visit like baseline, week 4, Week 8, and Week 12)
研究者
Dr Megha C
CUTIS Academy of Cutaneous Sciences