| CTRI Number |
CTRI/2025/05/087116 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Study Comparing Laser Treatment and Vitamin D Injections for Keloid Scar Reduction"
|
|
Scientific Title of Study
|
EFFICACY OF Q SWITCHED Nd YAG LASER VERSUS INTRALESIONAL VITAMIN D INJECTION IN THE TREATMENT OF KELOIDS A COMPARATIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunnam Lakshmi Rasajna |
| Designation |
Postgraduate |
| Affiliation |
Rajahmundry |
| Address |
Department of DVL,
Room number E1,First floor,
GSL Medical college,
NH16 , Lakshmipuram , Rajamahendravaram , Andhra pradesh
Department of DVL,
Room number E1,First floor,
GSL Medical college,
NH16 , Lakshmipuram , Rajamahendravaram , Andhra pradesh
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
8500004555 |
| Fax |
|
| Email |
rasajnagunnam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V V V Satyanarayana |
| Designation |
Professor |
| Affiliation |
GSL medical college and general hospital, Rajahmundry |
| Address |
Department of DVL,
Room number E1,First floor,
GSL Medical college,
NH16 , Lakshmipuram , Rajamahendravaram , Andhra pradesh
Department of DVL,
Room number E1,First floor,
GSL Medical college,
NH16 , Lakshmipuram , Rajamahendravaram , Andhra pradesh
East Godavari
ANDHRA PRADESH
533003
India |
| Phone |
9963744345 |
| Fax |
|
| Email |
vellasatyanarayana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V V V Satyanarayana |
| Designation |
Professor |
| Affiliation |
GSL medical college and general hospital, Rajahmundry |
| Address |
Department of DVL,
Room number E1,First floor,
GSL Medical college,
NH16 , Lakshmipuram , Rajamahendravaram , Andhra pradesh
Department of DVL,
Room number E1,First floor,
GSL Medical college,
NH16 , Lakshmipuram , Rajamahendravaram , Andhra pradesh
East Godavari
ANDHRA PRADESH
533003
India |
| Phone |
9963744345 |
| Fax |
|
| Email |
vellasatyanarayana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of DVL,
Room number E1,First floor,
GSL Medical college,
NH16 , Lakshmipuram , Rajamahendravaram , Andhra pradesh,India |
|
|
Primary Sponsor
|
| Name |
Gunnam Lakshmi Rasajna |
| Address |
Department of DVL,
Room number E1,First floor,
GSL Medical college,
NH16 , Lakshmipuram , Rajamahendravaram , Andhra pradesh,India |
| Type of Sponsor |
Private medical college |
|
|
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 Gunnam Lakshmi Rasajna |
GSL MEDICAL COLLEGE AND GENERAL HOSPITAL |
NH16 , Lakshmipuram , Rajamahendravaram , Jagannandhapuram ,Agraharam, Andhra pradesh
533296
East Godavari
ANDHRA PRADESH |
08500004555
rasajnagunnam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committe GSL medical college &General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L987||Excessive and redundant skin and subcutaneous tissue, (2) ICD-10 Condition: L987||Excessive and redundant skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Vitamin D |
Two symmetrical keloid lesions on the body are selected For one lesion Injection vitamin D is given |
| Intervention |
Laser treatment |
Two symmetrical keloid lesions on the body are selected
For one lesion Q switched Nd YAG laser will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
keloids of similar size
keloid of size not more than 5cms
patients who voluntarily will give the informed consent |
|
| ExclusionCriteria |
| Details |
pregnant and lactating females and
Keloids on face |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of height, pliability vascularity pigmentation pain pruritus of keloids in two symmetrical lesions |
outcome will be assessed at baseline 2 weeks 4weeks and 1 month after final sitting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement of height, pliability, vascularity pigmentation, pain, pruritus, of keloids |
4 sessions |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/05/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Keloids are benign fibrous growths that result from an abnormal response to tissue trauma, extending beyond the original site of injury. They are often accompanied by itching and pain. In the Asian population, the prevalence of keloids ranges from 0.2% to 5.2%.This study aims to determine whether Q-switched Nd YAG laser or Intralesional vitamin D injection is the superior, safer, and more effective method for managing keloids.Four sessions of Q-switched Nd YAG laser treatment and intralesional vitamin D injections will be administered two weeks apart. |