| CTRI Number |
CTRI/2025/01/079657 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare radiofrequency ablation and trichloroacetic acid (TCA) 50% chemical in xanthelasma patients. |
|
Scientific Title of Study
|
A comparative study of radiofrequency ablation(RFA) with wound suturing versus trichloroacetic acid (TCA) 50% in the treatment of xanthelasma palpebrum. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ketki |
| Designation |
Assistant Professor |
| Affiliation |
eras lucknow medical college and hospital |
| Address |
Department of Dermatology, Eras Lucknow Medical College and Hospital, Sarfaraz Ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9873701332 |
| Fax |
|
| Email |
ketkilhmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ketki |
| Designation |
Assistant Professor |
| Affiliation |
eras lucknow medical college and hospital |
| Address |
Department of Dermatology, Eras Lucknow Medical College and Hospital, Sarfaraz Ganj Lucknow
Department of Dermatology, Eras Lucknow Medical College and Hospital, Sarfaraz Ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9873701332 |
| Fax |
|
| Email |
ketkilhmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ketki |
| Designation |
Assistant Professor |
| Affiliation |
eras lucknow medical college and hospital |
| Address |
Department of Dermatology, Eras Lucknow Medical College and Hospital, Sarfaraz Ganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9873701332 |
| Fax |
|
| Email |
ketkilhmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eras Lucknow Medical College and Hospital , Lucknow, Uttar Pradesh India 226003 |
|
|
Primary Sponsor
|
| Name |
Eras Lucknow Medical College and Hospital Lucknow |
| Address |
Department of Dermatology, Eras Lucknow Medical College and Hospital, Sarfaraz Ganj Lucknow Uttar Pradesh India 226003 |
| 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 Ketki |
Eras Lucknow Medical College and Hospital |
Second floor, Department of Dermatology, Eras Lucknow Medical College and Hospital, Sarfaraz Ganj Lucknow Uttar pradesh
Lucknow
UTTAR PRADESH |
9873701332
ketkilhmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Eras Lucknow Medical College and Hospital , Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Radiofrequency ablation |
radiofrequency ablation followed by suturing Frequency- once Route - radiofrequency ablation over the lesions Follow up- 2 weeks, 4 weeks and 6 weeks Duration of study - 6 weeks After completion of trial period, treatment of the patient with the drug shall continue if necessary. |
| Intervention |
Trichloroacetic acid (50%) |
trichloroacetic acid Dose-50% Frequency- once in two weeks
Route - Topical application over the lesions Follow up- 2 weeks, 4 weeks and 6 weeks Duration of study - 6 weeks After completion of trial period, treatment of the patient with the drug shall continue if necessary. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical diagnosis of Xanthelasma palpebrum presenting in the Dermatology OPD of Eras Lucknow Medical College. |
|
| ExclusionCriteria |
| Details |
1) any active eyelid infection, eyelid eczema, keloidal tendency, patients with pacemaker, allergy to lidocaine, pregnant and lactating |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Radiofrequency ablation (RFA) with wound suturing versus Trichloroacetic acid (TCA) 50% in the treatment of xanthelasma palpebrum |
0, 2, 4, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study and compare the side effects of Radiofrequency ablation (RFA) with wound suturing versus Trichloroacetic acid (TCA) 50% in the treatment of xanthelasma palpebrum |
0, 2, 4, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
10/02/2025 |
| 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="0"
Months="6"
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
|
A total of 46 patients presenting to the Department of Dermatology, Eras Lucknow Medical College and Hospital, Lucknow with clinical diagnosis of xanthelasma palpebrum will be approached for participation in the study. Patients meeting the inclusion and exclusion criteria and giving written consent for participating in the study shall be recruited. History and clinical examination with photographic documentation will be done before starting treatment and then at each visit. Patients will be randomly divided into two groups – A and B each containing 23 individuals. In group A – Patients will be advised to apply Trichloroacetic acid (50%) once in 2 weeks over the lesion for 6 weeks. In group B – Patients will be advised for radiofrequency ablation of the lesion followed by wound suturing. sutures will be removed after 1 week. Results will be noted at each follow up at 2, 4 and 6 weeks and at each follow-up visit clinical response will be determined based on reduction in size as Mild improvement(<25% clearance),Moderate improvement(25-50% clearance),Good improvement(50-75% clearance) and Excellent improvement(>75% clearance). Final outcome will be noted at the end of 6th week. Side effects will be noted at each visit. |