Comparison of Outcome of Microneedling With Autologous Platelet Rich Plasma Verses Microneedling With Topical Insulin in the Treatment of Post-Acne Atrophic Scars
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars
研究概览
简要总结
Post acne scars are formed as a result of very inflamed and nodulocystic acne. Most common type of acne scars are atrophic scars and they are further classified on the basis of depth and size of destruction into ice pick, boxcar and rolling scars. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars as to find out the relatively more effective and safer treatment.
详细描述
Acne vulgaris is a disease involving inflammation or blockage of pilosebaceous units. Post acne scars are formed as a result of very inflamed and nodulocystic acne. There are many procedures to treat post-acne scar including lasers, platelet rich plasma, fillers, chemical peeling, pulsed dye lasers, fractional CO2 lasers, subcision and punch techniques, but almost lead to additional scaring and pigmentation.The major purpose of our study is comparison of outcome of micro-needling and platelet rich plasma as opposed to combining it with topical in atrophic scars due to acne, as topical insulin is natural component of body, cheap, easy to use, minimally invasive and a new therapy for post-acne scars. No local study was found in literature research. Hence, any effect of this potentially very effective therapeutic modality needs to be investigated.
OBJECTIVE
"To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars".
Material & Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion & exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will includes 60 patients which will be divided into 2 groups A & B, 30 in each group. Group A will receive micro-needling with topical application of 2ml of human actrapid insulin. Group B will receive micro-needling with topical application of 2ml Platelet rich plasma. Face of the patient will be washed after 30 mints and patients will be strictly instructed regarding sun protection at least 1 day after the procedure. Blood glucose level will be checked prior to and 30 mints following procedure.
At monthly interval for total 4 sessions and follow up visit will be after 2 months of last session.Data will be analyzed by SPSS v25.0.
Chi-square test will be applied for qualitative variables and t-test will be used for quantitative variables.
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
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 13-50 years
- •Gender: both male and female
- •Type of acne scar: Atrophic acne scar
- •Patients not taking prior treatment in last 1-2 months
排除标准
- •Pregnancy and lactating females
- •Bleeding disorders
- •Platelet count less than 100000
- •Hypersensitivity to insulin, PRP
- •Keloidal tendency
- •Active herpes simples, warts and molluscum contagiosum
- •Unrealistic expectations
研究组 & 干预措施
Micro-needling with topical human actrapid insulin group (Group A)
Patients with post-acne atrophic scars will receive micro-needling with topical application of 2ml of human actrapid insulin
干预措施: micro-needling with topical human actrapid insulin (Procedure)
Micro-needling with topical Platelet rich plasma(Group B)
Patients with post-acne atrophic scars will receive micro-needling with topical application of 2ml Platelet rich plasma
干预措施: Micro-needling with topical Platelet rich plasma (Procedure)
结局指标
主要结局
To compare the outcome of microneedling with autologous platelet rich plasma verses microneedling with topical insulin in the treatment of post-acne atrophic scars
时间窗: Clinical assessment for efficacy will be done monthly for 6 months
Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 6th month after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1.Remission: It is defined as complete resolution of all scar leaving behind normal skin. 2.Improvement: It is defined as a more than 50% healing of scars ,as clinically measured by the surface area from the baseline. 3.No improvement: It is defined as less than a 50% improvement in the healing of scars, as measured clinically by the surface area from the baseline.
次要结局
未报告次要终点
研究者
Mohibullah Zahidi
Post Graduate Resident in Dermatology
Sheikh Zayed Medical College