| CTRI Number |
CTRI/2025/11/097645 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparative study in patients of keloid with carbon dioxide laser and 2 different topical drugs to assess their efficacy in management of keloids |
|
Scientific Title of Study
|
A comparative study to determine the efficacy of topical Pirfenidone with Carbon dioxide laser versus Emollient with Carbon dioxide laser in the management of keloid |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjeevani Gupta |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College , Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Dermatology , Venereology and Leprosy , Jawaharlal Nehru Medical College
Datta Meghe Institute Of Higher Education And Research , Sawangi,(Meghe )Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9621932304 |
| Fax |
|
| Email |
sanjeevani1906@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHUSHAN MADKE |
| Designation |
HOD and Professor |
| Affiliation |
Jawaharlal Nehru Medical College , Datta Meghe Institute Of Higher Education And Research , |
| Address |
Jawaharlal Nehru Medical College , Datta Meghe Institute Of Higher Education And Research ,Sawangi(Meghe)Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
7066887353 |
| Fax |
|
| Email |
drbhushan81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeevani Gupta |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College , Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Dermatology , Venereology and Leprosy , Jawaharlal Nehru Medical College
Datta Meghe Institute Of Higher Education And Research , Sawangi,(Meghe )Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9621932304 |
| Fax |
|
| Email |
sanjeevani1906@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology , Venereology and Leprosy , Jawaharlal Nehru Medical College
Datta Meghe Institute Of Higher Education And Research , Sawangi,(Meghe )Wardha, Maharashtra , India
442107 |
| NIL |
|
|
Primary Sponsor
|
| Name |
Sanjeevani Gupta |
| Address |
Jawaharlal Nehru Medical College , Sawangi Meghe , Wardha
|
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Sanjeevani Gupta |
Acharya Vinobha Bhave Rural Hospital |
Sawangi, Meghe
Wardha
MAHARASHTRA |
9621932304
sanjeevani1906@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy humans with keloids |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Emollient |
A moisturiser which with act as placebo
twice daily , local application ,120 days |
| Intervention |
Topical Pirfenidone gel |
Drug delivery via carbon dioxide laser then application of topical Pirfenidone gel which has antifibrotic and anti inflammatory properties
twice daily , local application , 120 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged more than 18 years
Patients with clinically diagnosed keloid scars confirmed by history and examination
Willingness to avoid other scar treatments during the study period
Ability to give written informed consent
|
|
| ExclusionCriteria |
| Details |
Active infection or ulceration over or around the keloid site
History of keloid treatment within the past 3 months eg steroid injections, laser, cryotherapy
Patients on systemic steroids, immunosuppressants, or anticoagulants
Pregnant or lactating women
Known hypersensitivity or allergy to pirfenidone or laser procedures.
History of hypertrophic scars or other dermatological conditions mimicking keloids.
Patient with systemic diseases affecting wound healing uncontrolled diabetes, autoimmune disease
Patients with unrealistic expectations
HIV, Hepatitis C, Hepatitis B positive patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in keloid size , symptomatic relief and scar appearance
|
assessment after 4 weeks , 8 weeks . 12 weeks , 16 weeks , 20 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
RESEARCH QUESTION: Can topical Pirfenidone enhance the therapeutic outcomes of carbon dioxide laser treatment in patients with keloids more effectively than standard emollient care with carbon dioxide laser ? AIMS AND OBJECTIVE: • To evaluate the efficacy of topical Pirfenidone with CO2 laser therapy in keloid • To evaluate the efficacy of emollient with CO2 laser therapy in keloids • To compare the efficacy of efficacy of topical Pirfenidone with carbon dioxide laser vs emollient with CO2 laser therapy in keloids • To assess changes in scar characteristics using Detroit keloid scale STUDY DESIGN: Randomised Interventional Study PLACE OF STUDY: Outpatient department of Dermatology, Venereology & Leprosy, Acharya Vinoba Bhave Rural Hospital, Sawangi Wardha
STUDY POPULATION: Patients having keloid including both genders and >18 years of age, visiting to the department of Dermatology, Venerology and Leprosy (DVL),Acharya Vinoba Bhave Rural Hospital, Sawangi will be included in the study. INCLUSION CRITERIA: • Individuals aged more than 18 years • Patients with clinically diagnosed keloid scars (confirmed by history and examination). • Willingness to avoid other scar treatments during the study period. • Ability to give written informed consent. EXCLUSION CRITERIA: • Active infection or ulceration over or around the keloid site • History of keloid treatment within the past 3 months (e.g., steroid injections, laser, cryotherapy). • Patients on systemic steroids, immunosuppressants, or anticoagulants. • Pregnant or lactating women. • Known hypersensitivity or allergy to pirfenidone or laser procedures. • History of hypertrophic scars (not true keloids) or other dermatological conditions mimicking keloids. • Patient with systemic diseases affecting wound healing (e.g., uncontrolled diabetes, autoimmune disease). • Patients with unrealistic expectations
• HIV, Hepatitis C, Hepatitis B positive patients |