跳至主要内容
临床试验/CTRI/2022/12/048400
CTRI/2022/12/048400尚未招募不适用

A split face study to compare the efficacy of platelet rich plasma combined with micro needling versus micro needling alone for treatment of acne scars

Jeyashree1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To compare the mean reduction in acne scar using Goodman Baron quantitative scale of assessment for acne scars

研究概览

简要总结

  • Acne scar is a major cosmetic concern for a patient and presents a challenge to a dermatologists due to lack of effective treatment modalities.[10]
  • Although many treatment modalities are currently being used, they have shown improvement to a limited extent with possible side effects. (11)
  • Multiple minimally invasive sessions of micro needling is an effective treatment for post acne atrophic scars as it stimulates the repair processes with the advantage of being relatively risk free, in office procedure with minimal patient recovery time (12)
  • PRP provides various growth factors which aid in quick wound healing
  • This study proposes that PRP can be used as  an effective adjuvant therapy to be used along with standard micro needling therapy
  • All previously done studies showed no significant change in Goodman and barons score at the end point. This study is to perform the procedure in a Fitzpatrick 4 to 6 skin type with southern type of climatic conditions and to compare the efficacy and adverse effects.

研究设计

研究类型
Interventional
分配方式
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • grade 2 to grade 4 atrophic acne scars (based on Goodman and Baron’s qualitative classification) ,with quantitatively equal scores on both halves of the face ,without any active acne and who are willing to participate in the study.

排除标准

  • 1.Positive history of keloidal tendency.
  • 2.Positive history of bleeding or platelet disorder.
  • 4.Presence of any acute infection on face like, herpes, folliculitis.
  • 5.Patients of HIV, HBsAg, or any chronic illness.
  • 6.Pregnancy.

结局指标

主要结局

To compare the mean reduction in acne scar using Goodman Baron quantitative scale of assessment for acne scars

时间窗: 4 months

次要结局

  • compare photographs pre and post treatment of both sides of the face using the assessment by an independent physician (dermatologist)
  • compare patient satisfaction scores for either side of the face before treatment and 1month after the end of the last session(4 months)

研究者

发起方
Jeyashree
申办方类型
Other [Self ]

研究点 (1)

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