Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical response by (ECCA) scale
研究概览
简要总结
This study aimed to evaluate the efficacy of dermaroller and topical vitamin C- either separate or combined- in treatment of post acne scars.
prospective randomized clinical trial that was The study was a randomized controlled trial, conducted in Sohag Dermatology outpatient clinic between June 2016 and of February 2018. 30 patients with acne scars were included.
All patients were informed about the entire procedure, medication, possible side effects and outcomes. A written informed consent was signed from each participant.
详细描述
Study population:
Each study group included 10 patients. Detailed history and full clinical examination was conducted for each patient. Patients had 6 visits at one month interval to receive treatment and evaluated one month after the end of treatment visits.
The first group:
Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions.
The second group:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Facial acne scars
排除标准
- •Active inflammatory acne.
- •Active infection in the treatment area (e.g., herpes simplex and verrucae).
- •Melanoma or lesions suspected of malignancy.
- •Isotretinoin use in the past year.
- •Dermatoses (e.g., eczema and psoriasis).
- •Anticoagulant therapy.
- •Systemic disease (diabetes, hypertension, collagen disease or bleeding tendency).
研究组 & 干预措施
Dermaroller arm
Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions.
干预措施: Dermaroller (Device)
Dermaroller + topical Vit. C arm
Patients received a series of six treatments by dermaroller at 4 weeks interval with the same maneuver and instructions as first group and each session was followed by immediate application of topical vitamin C serum plus once daily application in between sessions.
干预措施: Dermaroller (Device)
Dermaroller + topical Vit. C arm
Patients received a series of six treatments by dermaroller at 4 weeks interval with the same maneuver and instructions as first group and each session was followed by immediate application of topical vitamin C serum plus once daily application in between sessions.
干预措施: Topical Vitamin C (Drug)
Topical Vit. C arm
Patients received once daily topical vitamin C serum capsule at night for six months. With monthly evaluation.
干预措施: Topical Vitamin C (Drug)
结局指标
主要结局
Clinical response by (ECCA) scale
时间窗: 9 months
Assessment of clinical response before intervention,after each session and at monthly intervals for 3 months after the end of sessions. Echellad'e valuation Clinique des cicatrices d'acne (ECCA) scale was used for numerical grading of acne scars.The ECCA grading scale is a tool designed to help dermatologists to assess the severity of acne scars and to standardize the discussions about the treatments of scars. The scale grades from no scar (grade = 0) to many scars (grade= 3)
次要结局
- Patient satisfaction questionnaire(9 months)
研究者
Rasha Ismail
Assistant lecturer, Department of Dermatology, Venereology and Andrology
Sohag University