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临床试验/NCT07154030
NCT07154030尚未招募1 期

Efficacy Of Combined Microneedling Plus Tretinoin 0.025% Or Timolol 0.5% In Treatment Of Stria Rubra

Sohag University0 个研究点目标入组 300 人开始时间: 2025年9月5日最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
300
主要终点
Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes

研究概览

简要总结

Striae distensae (SD), commonly known as stretch marks, are linear dermal scars accompanied by epidermal atrophy . They are often associated with psychological morbidity with a negative impact on quality of life .They are mainly caused by marked stretching in the skin leading to dermal damage and epidermal thinning, leading to linear atrophic scars .

Stretch marks are more common in women , their prevalence in puberty range from 6% to 86% and in obesity, it is 43%. Striae gravidarum (SG), (stretch marks of pregnancy) range between 50% and 90% ,and are more common in younger women.

详细描述

Striae distensae are most commonly found on the thighs, buttocks, and breasts in girls, and on the lumbosacral area or the outside surface of the thighs in boys. SG appears in the third trimester on the abdomen, breasts or thighs. They are more common in young primigravidae and are linked to higher pregnancy weight, large for gestational age new born, and a higher risk of traumatic vaginal birth .

The SD comes in two forms: striae rubrae (SR) and striae alba (SA). The initial erythematous, stretched flat lesions that are aligned perpendicular to the direction of skin tension represent the acute stage (SR) and they can cause mild itching. The chronic stage (SA) is described when SD have faded and appears atrophic, wrinkled and hypopigmented .

The most common causes of SD include a growth spurt during puberty, pregnancy, positive family history, obesity, and rapid weight gain or loss . Genetic causes including Marfan syndrome, Ehler-Danlos syndrome, and ectodermal dysplasia .

Other causes include cushing disease, anorexia nervosa, infections like T.B and typhoid, chronic liver disease and impaired elastic fibres of dermis. Iatrogenic causes include long term use of topical and systemic steroids and anti-retroviral drugs . Overstretching of the skin lead to dermal damage with inflammatory edema leading to rupture of collagen, elastin and fibronectin. Additionally, there is a defect in fibroblast function, with decrease in fibrillin and elastin production and lack of collagen organization . The treatment modalities for SD range from topical agents to more advanced laser and energy-based devices . Topical treatments such as tretinoin and glycolic acid are widely used for their ability to enhance collagen production and improve skin texture.

Lasers and light devices, particularly fractional CO2 lasers, efficiently promote dermal remodeling and improve the appearance of both SR and SA. No single therapy has emerged as the "gold standard," and combination therapies are recommended . Microneedling as a method of treating stretch marks, stimulates intradermal collagen production , also it can be used as a method of achieving trans-epidermal drug delivery.it also helps elimination of damaged old collagen . Microneedling leads to the release of several growth factors, including platelet-derived growth factors, fibroblast growth factors, and transforming growth factors alpha and beta, which stimulate the migration and proliferation of fibroblasts, producing new collagen and elastin in the papillary dermis. In addition, new capillaries are formed, this neovascularization and neocollagenesis following treatment lead to reduction of scars. The procedure is therefore called "percutaneous collagen induction therapy" .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The study will include patients with stria rubra aged ≥18

排除标准

  • - 1.Pregnant & lactating patients. 2.Patients with bleeding disorders or on anticoagulant therapy. 3.Patients using drugs that exacerbate the striae as systemic corticosteroids in the preceding two months or topical corticosteroid in the preceding one month.
  • 4.Patients having active infection at the treatment area. 5.Patients with keloidal tendency. 6.Patients using other forms of treatment for stria as emollients, glycolic acid peel and laser over the last 2 months.

结局指标

主要结局

Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes

时间窗: 12 months

Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kholoud Mostafa Hashem

demonstrator od dermatology

Sohag University

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