| CTRI Number |
CTRI/2024/12/077520 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of Fractional CO2 laser against Intralesional Triamcinolone Acetonide in the treatment of Keloid |
|
Scientific Title of Study
|
Comparison of Effectiveness of Fractional CO2 Laser against Intralesional Triamcinolone Acetonide in the treatment of Keloids |
| 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 Deepak Mudgal |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Dermatology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7786927059 |
| Fax |
|
| Email |
mudgaldeepak20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hanamant Ganapati Bobade |
| Designation |
Associate professor Dermatology |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Dermatology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9082382906 |
| Fax |
|
| Email |
hanamant.b@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niraj |
| Designation |
Associate professor Dermatology |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Dermatology Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7759856253 |
| Fax |
|
| Email |
drniraj1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur, 242307 |
|
|
Primary Sponsor
|
| Name |
Dr Deepak Mudgal |
| Address |
Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, India, 242307 |
| 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 |
| Dr Deepak Mudgal |
Varun Arjun Medical College and Rohilkhand Hospital |
Room No: 234, Department of Dermatology, Varun Arjun Medical College and Rohilkhand Hospital, Banthra
Shahjahanpur
UTTAR PRADESH |
7786927059
mudgaldeepak20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VAMC, Banthra, Shahjahanpur, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L919||Hypertrophic disorder of the skin,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional CO2 Laser |
Patients with Keloid will be treated with Fractional CO2 Laser for 3 months |
| Comparator Agent |
Intralesional triamcinolone acetonide |
Patients with Keloid will be treated with Intralesional triamcinolone acetonide injection for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with keloids.
2. Patients aged 18 years and above.
3. Patients having keloids of size 1cm to 20cm in greatest dimension.
4. Patients willing to undergo either fractional CO2 laser therapy or intralesional triamcinolone acetonide injections.
5. Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with a past of allergic reaction or contraindications to triamcinolone acetonide injections.
2. Individuals with active skin infections or other dermatological conditions that may interfere with keloid treatment.
3. Patients who have undergone treatment for keloid within the past 6 months.
4. Pregnant or breastfeeding individuals.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of improvement of height with fractional co2 laser against intralesional triamcinolone acetonide in the treatment of keloids |
Once every month for six month
Once every three month for six month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of improvement of texture with fractional co2 laser against intralesional triamcinolone acetonide in the treatment of keloids |
Once every month for six month
Once every three month for six month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/12/2024 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mudgaldeepak20@gmail.com].
- For how long will this data be available start date provided 29-07-2026 and end date provided 29-07-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study “COMPARISON OF EFFECTIVENESS OF FRACTIONAL CO2
LASER AGAINST INTRALESIONAL
TRIAMCINOLONE ACETONIDE IN
THE TREATMENT OF KELOIDS†will be conducted in the Department of Dermatology, Venerology & Leprosy, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh 242307
The study will be conducted on subjects with Keloid attending the outpatient clinic in the Department of Dermatology, Venerology & Leprosy, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh based on inclusion and exclusion criteria.
All patients selected for the study will undergo detailed history taking and written informed consent.
Patients will be allocated randomly into 2 groups
Group A will receive fractional CO2
laser therapy
Group B will receive intralesional
triamcinolone acetonide injections |