Efficacy and Safety of Combined Microneedling With Topical Glutathione Versus Carboxy Therapy in Treatment of Patients With Periorbital Hyperpigmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change of periorbital hyperpigmentation through photo evaluation
研究概览
简要总结
Periorbital hyperpigmentation (POH) is a common condition in dermatology practice. Periorbital hyperpigmentation is defined as bilateral, round, homogeneous pigmented macules.The etiology of POH is multifactorial including genetic and enviromental factors. Many treatment options are avaiblabe with variable efficacy and safety in different patients. Therefore, the investigator's study aims to evaluate the efficacy and safety of combined microneedling with topical Glutathione versus Carboxy Therapy in treatment of patients with periorbital hyperpigmentation.
详细描述
Periorbital hyperpigmentation (POH) is a common skin condition which has a great negative effect on the patient quality of life. Many factors contribute in the pathogensis of POH which lead to developement of several treatment options with no treatment option has a great sucess in improving the POH and patient quality of life. Our current study tries to explore the efficacy and safety between 2 treatment methods in a split face study.
Microneedling is a process of making small punctres into the skin through small needles by device which is called a Dermapen. This microneedling method is beleived to be associated with improving the skin quality through increased collagen. This microneedling will be followed by topical application of glutathione which is a commong antioxidant with whitening effects.
Carboxy therapy is a new emerging treatment option in many dermatological diseases. It will be used in POH patients as it will be able to increase blood flow in periorbital area and improve the skin qulaity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both patients and the outcome assessors were blinded to the type of treatment which was done in each eye
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with Periorbital hyperpigmentation
排除标准
- •Pregnancy and lactation .
- •Allergy, hypersensitivity to the formulations to be used in the study.
- •Any other cutaneous or systemic disease.
- •Patient who had taken any other treatment (laser, dermabrasion) on the affected region performed less than 6 months prior to the beginning of the study.
结局指标
主要结局
Change of periorbital hyperpigmentation through photo evaluation
时间窗: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
High-resolution photographs of both sides of the face were taken. Using a physician visual analog scoring system, 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows 1 (worse), 2 (no change), 3 (\<30%), 4 (30-60%), and 5 (\>60%)
Change of the patient satisfaction evaluation: scale
时间窗: Baseline and 1 month after end of treatment
The patients were asked to evaluate their own level of satisfaction after they completed the study on a 1-3 scale: 1 = slightly satisfied, 2 = moderately satisfied, and 3 = well satisfied
Change of periorbital hyperpigmentation through dermoscopy evaluation
时间窗: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Dermoscopic evaluation was done using dermalite connection kit for Samsung galaxy. 2 independent blinded dermatologists will rate the patient's overall aesthetic improvement as follows * Vasculature improvement (No 0, Yes 1) \& percent of improvement. * Pigmentation improvement (No 0, Yes 1) \& percent of improvement. * Skin improvement like atrophy and exaggerated skin markings (No 0, Yes 1) \& percent of improvement.
Change of periorbital hyperpigmentation into another skin problem through safety evaluation
时间窗: Baseline, before 3rd session, before 5th session, 1 month after end of treatment, 2 months after end of treatment
Safety evaluation to detect precentage of side effects reported either by the patient or by the physician.
次要结局
- The Dermatology Life Quality Index questionnaire(Baseline, before 3rd session, before 5th session,)
研究者
Amr Abdelhamed
Lecturer of Dermatology, Venereology & Andrology
Sohag University