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CTRI Number  CTRI/2025/10/096564 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study On Clinical Profile Of Acne Scars In Patients With Skin Of Colous At A Tertiary Care Hospital In Western India 
Scientific Title of Study   A Study On Clinical Profile Of Acne Scars In Patients With Skin Of Colous At A Tertiary Care Hospital In Western India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apoorva S Daga 
Designation  1st year PG Resident 
Affiliation  GCS Medical College Hospital and Research Centre 
Address  OPD 35,Ground floor, GCS Medical College Hospital and Research Centre Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad Ahmedabad GUJARAT 380025 India Ahmadabad GUJARAT 380025 India

Ahmadabad
GUJARAT
380025
India 
Phone  8758686711  
Fax    
Email  apoorvadagawork@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nayan H Patel 
Designation  Professor and HOD 
Affiliation  GCS Medical College Hospital and Research Centre 
Address  OPD 35, ground floor,GCS Medical College Hospital and Research Centre,Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad Ahmedabad GUJARAT 380025 India Ahmadabad GUJARAT 380025 India

Ahmadabad
GUJARAT
380025
India 
Phone  9925011309  
Fax    
Email  nayan.patel@gcsmc.org  
 
Details of Contact Person
Public Query
 
Name  Dr Nayan H Patel 
Designation  Professor and HOD 
Affiliation  GCS Medical College Hospital and Research Centre 
Address  OPD 35, ground floor,GCS Medical College Hospital and Research Centre,Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad Ahmedabad GUJARAT 380025 India Ahmadabad GUJARAT 380025 India

Ahmadabad
GUJARAT
380025
India 
Phone  9925011309  
Fax    
Email  nayan.patel@gcsmc.org  
 
Source of Monetary or Material Support  
GCS Medical College Hospital And Research Centre, Ahmedabad, Gujarat 380025 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Apoorva S Daga  GCS Medical College Hospital & Research Centre  Department of dermatology GCS Medical College Hospital and Research Centre Opp DRM Office Near Chamunda Bridge Naroda Road Ahmedabad Ahmadabad GUJARAT Ahmadabad GUJARAT
Ahmadabad
GUJARAT 
8758686711

apoorvadagawork@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee GCS medical college,hospital and research centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
1. Age 12 years and above.
2. Patients with Fitzpatrick skin types three, four, five and six.
3. Patients with clinically diagnosed acne scars for example atrophic, hypertrophic, or mixed.
4. Willingness to participate and provide Informed Consent. 
 
ExclusionCriteria 
Details  Exclusion Criteria
1. Patients with Fitzpatrick skin types one or two.
2. Patients with secondary causes of scarring other than acne for example trauma ,surgery ,burns ,varicella ,other dermatoses.
3. Pregnant & lactating patients.
4. Patients unwilling to participate and provide Informed Consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
co-primary objectives assessed at baseline in patients of skin of colour i.e Fitzpatrick 3to6
1To estimate the prevalence of acne scars.
2To estimate the associated risk factors of acne scars.
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.
4To observe Psychological impact via Dermatology life quality index,The Cardiff Acne Disability Index. 
It is a cross sectional study  
 
Secondary Outcome  
Outcome  TimePoints 
B. Secondary objectives to be assessed at baseline

1. To observe efficacy & safety of various therapeutic treatment modalities by grading of acne scars with the help of baseline & post procedural clinical examinations, objectively by using validated scoring systems like Goodman Baron qualitative & Goodman Baron quantitative scale & subjectively by using psychological impact assessment questionnaires like Dermatology life quality index, The Cardiff Acne Disability Index.  
It is a cross sectional study 
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 
 
Target Sample Size   Total Sample Size="318"
Sample Size from India="318" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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