Assessment of Serum Catestatin Level in Acne Vulgaris Patients Before and After Treatment With Oral Isotretinoin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evalaute serum level of Catestatin in acne patient
研究概览
简要总结
Acne vulgaris is a persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults.
Catestatin, a peptide derived from chromogranin A (CgA), was first discovered in 1997 as an acute nicotinic-cholinergic antagonist. Later, it was determined that CST is a pleiotropic hormone.
详细描述
Acne vulgaris is a persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults.
Four factors are thought to be linked to the physiopathology of acne: changes in the keratinization process of corneocytes, which results in the development of comedones; follicular proliferation of the bacterium Cutibacterium acnes; increased production of inflammatory mediators, including interleukins (IL)-1β; and increased sebum production by the sebaceous gland.
The distinctive lesions can be classified as either inflammatory (papules, pustules, nodules, and cysts) or non-inflammatory (open/black and closed/white comedones). Both types of lesions cause skin pigmentation and scarring, which need consistent treatment. Lesions are usually found on the chest, upper back, neck, and face.
There are wide variety of topical and oral therapy methods can be used for acne treatment. Topical retinoids, benzoyl peroxide, azelaic acid, and their combinations are considered first-line agents. Oral drugs such as oral antibiotics, isotretinoin, or hormonal therapy may be used to treat refractory or more severe acne.
The most effective treatment for acne is still isotretinoin (13-cis-retinoic acid), an oral retinoid that was licensed in 1982 for the treatment of acne vulgaris. Multiple randomized controlled trials have confirmed that it is more effective than oral antibiotics and placebos at reducing the number of acne lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy persons of both sexes with moderate and severe acne.
排除标准
- •Pregnant and lactating women.
- •Immunocompromised patients.
- •Severe anemia.
- •History of chronic liver disease.
- •Hyperlipidemia
- •Non-inflammatory acne conditions.
- •History of neurologic disorders.
- •History of neoplastic disorders.
- •History of cardiac disease.
- •History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
- •Cases with known hypersensitivity reaction to isotretinoin.
研究组 & 干预措施
Group I (Study Group)
About 30 patients suffering from moderate and severe acne Vulgaris
干预措施: Isotretinoin (Drug)
Group II (Control Group)
About 30 Healthy persons
干预措施: Isotretinoin (Drug)
结局指标
主要结局
Evalaute serum level of Catestatin in acne patient
时间窗: 12 weeks
Assessment of clinical improvement according to:(8) G4(excellent:100% reduction) G3(good:75-99% reduction) G2(moderate: 50-74% reduction) G1(insufficient :1-49% reduction) G0(unchanged) G-1(worse)
Evalaute the effect of treatment with systemic isotretinon
时间窗: 12 weeks
Evaluate the effect of treatment with systemic isotretinon therapy (0.5 mg/kg/day, up to 40 mg daily) on the level of serum Catestatin on the Participants whom suffering from Acne Vulgaris whether moderate or severe.
次要结局
未报告次要终点
研究者
Mona Zakaria Mohamed
Resident of Dermatology, at Faculty of medicine
Aswan University