| 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
|
|
|
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
|
|
|
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. |