| CTRI Number |
CTRI/2025/03/082114 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparing effects of two different treatments in participants with vitiligo |
|
Scientific Title of Study
|
Efficacy of Platelet Rich Plasma and 308nm Excimer laser versus 308nm Excimer laser alone in stable vitiligo patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KARNATI LAKSHMI VENKATA VIKRAMNATH REDDY |
| Designation |
POST GRADUATE |
| Affiliation |
GSL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
Room no 2, Department of DVL, GSL Medical College, NH-16, Lakshmipuram, Rajamahendravaram, 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9440466758 |
| Fax |
|
| Email |
drvikkiklv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR G VENKATA RAMANA |
| Designation |
PROFESSOR, DEPARTMENT OF DVL, GSL MEDICAL COLLEGE |
| Affiliation |
GSL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
Room no 1, Department of DVL, GSL Medical College, NH-16, Lakshmipuram, Rajamahendravaram, 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9246345937 |
| Fax |
|
| Email |
aidsandsex@rocketmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KARNATI LAKSHMI VENKATA VIKRAMNATH REDDY |
| Designation |
POST GRADUATE |
| Affiliation |
GSL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
Room no 2, Department of DVL, GSL Medical College, NH-16, Lakshmipuram, Rajamahendravaram, 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9440466758 |
| Fax |
|
| Email |
drvikkiklv@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSL Medical College, NH-16, Lakshmipuram, Rajamahendravaram, 533296 |
|
|
Primary Sponsor
|
| Name |
GSL Medical College |
| Address |
GSL Medical College, NH-16, Lakshmipuram, Rajamahendravaram, 533296 |
| 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 KARNATI LAKSHMI VENKATA VIKRAMNATH REDDY |
GSL General Hospital |
Room no 2, Department of DVL, GSL Medical College, NH-16, Lakshmipuram, Rajamahendravaram, 533296
East Godavari
ANDHRA PRADESH |
9440466758
drvikkiklv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GSL Medical college and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Platelet Rich Plasma and 308nm Excimer Laser |
Platelet Rich Plasma for both lesions monthly once for 4 months and 308nm Excimer laser for only one lesion weekly twice or thrice for 4 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18-60 years.
2)Vitiligo patients with stable lesions for at least one year.
3)Patients who are willing to give consent. |
|
| ExclusionCriteria |
| Details |
1)Patients with unstable vitiligo.
2)Patients who are not willing to give consent.
3)Infections.
4)Patients with bleeding disorders.
5)Patients on anticoagulants.
6)Pregnant and breastfeeding women.
7)Patients with history of skin cancer, keloid, hypertrophic scar, psoriasis, lichen planus, photosensitivity disorders and Koebner’s phenomenon. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study is expected to reveal the efficacy of combining Platelet Rich Plasma with 308-nm Excimer laser therapy compared to 308-nm Excimer laser therapy alone in Stable Vitiligo lesions. |
Baseline and after 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects will be noted for both Platelet Rich Plasma & Excimer Laser treatments during each visit |
Baseline & weekly twice for 4 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 3 |
|
Date of First Enrollment (India)
|
21/03/2025 |
| 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
|
Vitiligo is characterized by depigmented macules causing cosmetic disability, which results in great psychosocial stress. Many treatment methods are available for vitiligo. Many a time, medical therapy alone is not satisfactory. 308-nm excimer laser has proved to be effective in the treatment of limited vitiligo. Platelet-rich plasma (PRP) is an autologous blood product having a large concentration of platelets which contains variety of growth factors which may stimulate melanocyte proliferation and re-pigmentation in the vitiligo lesions. Though there are studies about Excimer Laser or Platelet rich Plasma in vitiligo individually, there are no studies regarding combination of 308-nm excimer laser with platelet rich plasma in the treatment of stable vitiligo lesions from India. Hence, this study will add value to the literature. |