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临床试验/CTRI/2025/10/096564
CTRI/2025/10/096564尚未招募不适用

A Study On Clinical Profile Of Acne Scars In Patients With Skin Of Colous At A Tertiary Care Hospital In Western India

未提供1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2025年11月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
318
试验地点
1
主要终点
co-primary objectives assessed at baseline in patients of skin of colour i.e Fitzpatrick 3to6

研究概览

简要总结

Acne scarring is a prevalent and distressing consequence of acne vulgaris, particularly affecting individuals with Skin of Colour that is Fitzpatrick grade three to six. This study aims to investigate the clinical profile of acne scars in Indian patients with Skin of Colour at a tertiary care hospital in Western India, addressing critical gaps in the understanding and management of this condition as they are seen to have a higher propensity for post-inflammatory hyperpigmentation , specific scar morphologies like hypertrophic scars and keloids, and increased risk of adverse effects from certain treatments like fractional carbon dioxide laser.

The research questions guiding this study are as follows,

What is the Prevalence, Clinical Patterns, Associated Risk Factors, Efficacy and Safety of various treatment modalities used for Acne Scarring in Indian Patients with Skin of Colour that is Fitzpatrick grade three to six at a Tertiary Care Hospital ?

The study will be a hospital-based observational study conducted at the Dermatology OPD of GCSMCH and RC, Ahmedabad. A total of 318 consenting patients, aged 12 years and above, with post-acne scarring and Fitzpatrick skin types three to six will be enrolled.

Data collection will involve a pre-designed Case Report Form to capture sociodemographic details, acne and its scars history, clinical examination findings. Standardized digital photography will be used for do baseline documentation and follow-up assessments.

The co-primary objectives of the study to estimate the prevalence, associated risk factors, clinical patterns, and types of acne scars in patients with Skin of Colour, and to observe the severity and grades of acne scars using validated scoring systems and psychological impact assessment questionnaires.

Secondary objectives include observing the efficacy and safety of various therapeutic treatment modalities and recording any adverse events.

 Expected Outcomes and Significance of this study are as follows,

This research is expected to provide valuable baseline data on the epidemiology and clinical spectrum of acne scarring in the Skin of Colour population in western Gujarat. It will also offer insights into the efficacy and safety of common treatment modalities in this population, contributing to the development of tailored prevention strategies

and optimized management protocols, potentially minimizing the risk of treatment-related complications like post inflammatory hyperpigmentation and ultimately improving overall patient outcomes at this tertiary care hospital and potentially beyond.

To ensure accurate documentation and facilitate follow-up assessments, standardized photographs of the affected areas will be taken .

The study will adhere to the guidelines set by Indian Council of Medical Research and will ensure ethical considerations, including obtaining informed consent, ensuring confidentiality, and minimizing risks to participants.

研究设计

研究类型
Observational

入排标准

年龄范围
12.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria
  • Age 12 years and above.
  • Patients with Fitzpatrick skin types three, four, five and six.
  • Patients with clinically diagnosed acne scars for example atrophic, hypertrophic, or mixed.
  • Willingness to participate and provide Informed Consent.

排除标准

  • Exclusion Criteria
  • Patients with Fitzpatrick skin types one or two.
  • Patients with secondary causes of scarring other than acne for example trauma ,surgery ,burns ,varicella ,other dermatoses.
  • Pregnant & lactating patients.
  • Patients unwilling to participate and provide Informed Consent.

结局指标

主要结局

co-primary objectives assessed at baseline in patients of skin of colour i.e Fitzpatrick 3to6

时间窗: It is a cross sectional study

1To estimate the prevalence of acne scars.

时间窗: It is a cross sectional study

2To estimate the associated risk factors of acne scars.

时间窗: It is a cross sectional study

3To observe the clinical features ,types, grades, severity of acne scars using scoring systems like Goodman Baron qualitative scale and quantitative scale, qualitative global acne scarring grading system.

时间窗: It is a cross sectional study

4To observe Psychological impact via Dermatology life quality index,The Cardiff Acne Disability Index.

时间窗: It is a cross sectional study

次要结局

  • B. Secondary objectives to be assessed at baseline
  • 2. To observe and record adverse events occurring, if any, in patients with the respective standard of care procedures planned for their treatment.(It is a cross sectional study)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Apoorva S Daga

GCS Medical College Hospital and Research Centre

研究点 (1)

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