Topical Silymarin Cream Versus Salicylic Acid Peeling in Treatment of Acne Vulgaris: Split Face Study
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
研究概览
简要总结
Acne vulgaris is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. Acne vulgaris is an extremely common condition with a lifetime prevalence of approximately 85% and occurs mostly during adolescence.
Acne vulgaris leads to significant morbidity that is associated with residual scarring and psychological disturbances such as poor self-image, depression, and anxiety, which leads to a negative impact on quality of life.
The treatment of acne vulgaris is challenging and often chronic, with high rates of failure and numerous choices. Frequent evaluations (i.e., every 8-12 weeks) are important to enable appropriate monitoring, manage adverse effects, and evaluate for medication compliance.
Topical therapies are considered one of the mainstay treatments for patients with mild-to-moderate acne.
详细描述
Chemical peeling is one of the most common cosmetic procedures in medical practice and has been used for decades. It is defined as the application of chemical agents, of variable strength, on the skin that results in controlled destruction of the epidermis and dermis. The induced exfoliation is followed by dermal and epidermal regeneration from adjacent epithelium and skin adnexa, which results in improved surface texture and appearance of the skin. This is a simple and cost-effective procedure with several dermatological applications.
Salicylic acid is a 2-hydroxybenzoic acid used for superficial peeling due to its strong keratolytic and comedolytic properties. It promotes shedding of epidermal cells and due to its lipophilic properties can penetrate comedones and pores to prevent clogging and neutralize bacteria. It promotes desquamation of the upper lipophilic layers of the stratum corneum. These chemical properties explain its popularity and success in acne patients. Also, it has well-documented anti-inflammatory properties.
Silymarin is a standardized extract from S. marianum seeds, is traditionally used as a hepatoprotective agent for its potent regenerative properties. Lately, Silymarin is utilized in dermatological and cosmetic preparations for its antioxidant effect anti-inflammatory and immunomodulatory properties.
Various studies have been created to evaluate the efficacy of Silymarin in UV protection, prevention against skin cancer and against actinic keratosis.
Silymarin showed efficacy the treatment of Rosacea, Melasma, Vitiligo, Psoriasis, atopic dermatitis and contact dermatitis . Other studies showed that Silymarin has anti aging properties and potential action for wound healing .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years of age.
- •Patients with mild and moderate acne vulgaris.
- •Patients with Fitzpatrick skin type III, IV and V.
排除标准
- •Severe acne.
- •Patients under treatment with contraceptive pills or any kind of systemic or topic acne medication (isotretinoin, antibiotics, topical products).
- •History of hypertrophic/keloid scar formation.
- •Pregnancy.
- •Recurrent herpes infection.
研究组 & 干预措施
Silymarin and salicylic acid
There will be one group of patients, that will use salicylic acid peeling on the right side of the face and topical Silymarin cream on the left side
干预措施: Silymarin (Combination Product)
结局指标
主要结局
Efficacy of the medication: number of inflammatory, non-inflammatory and total lesions
时间窗: 12 weeks
counting the number of inflammatory, non-inflammatory and total lesions at baseline and every 4 weeks during the treatment
assessment of tolerability: interviewing the patients
时间窗: 12 weeks
interviewing the patients about any sign/symptom of adverse reactions (erythema, peeling, burning sensation, dryness and pruritus)
次要结局
未报告次要终点
研究者
Alaa Gamal Ahmed Makhlouf
Principal investigator
Assiut University