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临床试验/CTRI/2024/03/063756
CTRI/2024/03/063756已完成不适用

A Split face comparison study of Fractional Co2 and Fractional Co2 With Tranexamic Acid In Acanthosis Nigricans

NA1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月14日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
The response to treatment will be evaluated by clinical examination and photographic comparison at baseline and during each follow up every month for 3 months post laser session.

研究概览

简要总结

Acanthosis nigricans (AN) is a chronic skin disorder that is characterized clinically by velvety darkening of the skin mainly at the back of the neck and also includes face, axilla, cubital fossa, knuckles and groin region. It is most commonly associated with diabetes and insulin resistance, or hormonal disorders, certain drugs such as steroids and oral contraceptives, and rarely internal malignancy. Thus, acanthosis nigricans is an indicator of metabolic syndrome in many diseases such as psoriasis, lichen planus, and atopic dermatitis.

Treatment is usually challenging. However, the condition usually improves by treating the cause as in the case of insulin resistance and weight loss. Other treatment modalities include keratolytics, such as topical retinoids (eg, topical tretinoin 0.1%), topical vitamin D analogues (eg, calcipotriol 0.005%), oral retinoids, octreotide, dermabrasion, and chemical peels with variable outcome.

In addition, various types of lasers have been used for managing AN as long-pulsed alexandrite laser, ablative carbon dioxide laser, fractional 1550-nm erbium fibre, and fractional CO2 laser with variable treatment results.

Fractional CO2 laser acts by fractionated photothermolysis by making skin columns of thermal injury known as micro-thermal zones. It improves the condition by removing thin layers of skin with minimal thermal damage leading to collagen injury and collagen remodelling. The latter helps in improving both the texture and thickness of the skin. In addition, transepidermal elimination of the dermal content is a possible mechanism by which the melanin is eliminated.

Tranexamic acid (TA) is an antifibrinolytic, reversibly binding to plasminogen, and thus preventing its conversion to plasmin and subsequent breakdown of fibrin. Additionally, TA reduces expression of vascular endothelial growth factor and endothelin-1, which also acts to minimize bleeding and hamper angiogenesis.

There remains a significant gap in comprehensive research focusing specifically on the combined efficacy of fractional CO2 laser therapy with tranexamic acid for treating AN. This study evaluates the need for fractional co2 and fractional co2 with tranexamic acid in acanthosis nigricans.

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

  • 1.Patients diagnosed with AN of the face.
  • 2.Age above 18 to 60 years.

排除标准

  • 1.Active herpes infection 2.Keloidal tendency/ scarring post laser 3.Pregnancy 4.Uncontrolled Diabetes 5.Systemic diseases as connective tissue disease 6.History of drug intake 7.Underlying malignancy 8.History of any procedures for treatment of AN at least 1 month before enrolment.

结局指标

主要结局

The response to treatment will be evaluated by clinical examination and photographic comparison at baseline and during each follow up every month for 3 months post laser session.

时间窗: After 3 m onths

次要结局

  • The response to treatment will be evaluated by clinical examination and photographic comparison at baseline and during each follow up every month for 3 months(Acanthosis Nigricans Area and Severity Index (ANASI) Score and Acanthosis Nigricans Scoring Chart done at baseline and after 6 weeks)

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Dr Madura C

CUTIS Academy of Cutaneous Sciences

研究点 (1)

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