| CTRI Number |
CTRI/2022/12/048379 [Registered on: 22/12/2022] Trial Registered Prospectively |
| Last Modified On: |
14/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of laser ablation and chemical ablation in facial verruca plana |
|
Scientific Title of Study
|
Efficacy and safety of erbium YAG laser vs salicylic acid and lactic acid flexible collodion paint in facial verruca plana: a comparative study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aakanksha Arora |
| Designation |
PG 3rd year dermatology resident |
| Affiliation |
Sardar Patel Medcal College, Bikaner |
| Address |
Department of dermatology, Sardar Patel medical college, Bikaner, Rajasthan
Bikaner
RAJASTHAN
334001
India |
| Phone |
09991065569 |
| Fax |
|
| Email |
akarora357@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aakanksha Arora |
| Designation |
PG 3rd year dermatology resident |
| Affiliation |
Sardar Patel Medcal College, Bikaner |
| Address |
Department of dermatology, Sardar Patel medical college, Bikaner, Rajasthan
RAJASTHAN
334001
India |
| Phone |
09991065569 |
| Fax |
|
| Email |
akarora357@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aakanksha Arora |
| Designation |
PG 3rd year dermatology resident |
| Affiliation |
Sardar Patel Medcal College, Bikaner |
| Address |
Department of dermatology, Sardar Patel medical college, Bikaner, Rajasthan
RAJASTHAN
334001
India |
| Phone |
09991065569 |
| Fax |
|
| Email |
akarora357@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel Medical College, Bikaner, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Sardar Patel medical college, Bikaner, Rajasthan |
| Address |
Department of dermatology, Sardar Patel medical college, Bikaner |
| Type of Sponsor |
Government 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 Rajesh Datt Mehta |
Sardar Patel Medical College |
Room no.5, department of dermatology
Bikaner
RAJASTHAN |
09829291502
mehtarddr@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical and Research Board, Sardar Patel Medical College, Bikaner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erbium YAG laser and Salicylic acid and lactic acid flexible collodion paint in facial verruca plana |
Er:YAG laser with the wavelength of 2940 nm spot size varying from 3 to 9mm fluence tailored to the skin type and type of lesion varying between 5 to 20 Joule will used to ablate the lesions every 14 days until the lesions cleared or upto maximum of 5 sessions. Salicyclic acid and lactic acid flexible collodion wart paint (16.7% each) will be applied to the lesions each time every 14 days till the clearance of lesions or upto maximum of 5 sessions. |
| Comparator Agent |
Erbium YAG laser in facial verruca plana |
Er:YAG laser with the wavelength of 2940 nm spot size varying from 3 to 9mm fluence tailored to the skin type and type of lesion varying between 5 to 20 Joule will used to ablate the lesions every 14 days until the lesions cleared or upto maximum of 5 sessions. |
| Comparator Agent |
Salicylic acid and lactic acid flexible collodion paint in facial verruca plana |
Salicyclic acid and lactic acid flexible collodion wart paint will be applied to the lesions each time every 14 days till the clearance of lesions or upto maximum of 5 sessions.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of facial verruca plana with at least four or more than four lesions, Age 12 to 65 years |
|
| ExclusionCriteria |
| Details |
Immunodeficiency
pregnancy and breastfeeding
history of hypertrophic scars or keloids
recurrent herpes infection
active secondary bacterial infection
photosensitivity
retinoid use within the last 6 months
collagen vascular disease
undergoing any other medical treatment within the last three months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The clinical response will be compared based on the clearance of lesions as
complete (100% lesion clearance), excellent (75–99%), good (50–75%), or poor ( 50% ) |
at the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects and recurrence rate |
at the end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/12/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our aim is to evaluate the efficacy and side effect profile of both the modalities i.e Er:YAG laser and Salicylic acid and lactic acid flexible collodion wart paint in facial verruca plana. |