| CTRI Number |
CTRI/2025/06/089309 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of combining CO2 laser with amorolfine 5 percent nail lacquer in
treatment of onychomycosis An open label randomised controlled trial |
|
Scientific Title of Study
|
Efficacy of combining CO2 laser with Amrolofine 5% nail laqure in
treatment of Onychomycosis- An open label randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shiwangi Rana |
| Designation |
Assistant Professor |
| Affiliation |
Department of Dermatology, AIIMS |
| Address |
Department of Dermatology,AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8860565443 |
| Fax |
|
| Email |
shivangi.rana356@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiwangi Rana |
| Designation |
Assistant Professor |
| Affiliation |
Department of Dermatology,AIIMS |
| Address |
Department of Dermatology,AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8860565443 |
| Fax |
|
| Email |
shivangi.rana356@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHIWANGI RANA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS |
| Address |
AIIMS GORAKHPUR
UTTAR PRADESH
273008
India |
| Phone |
8860565443 |
| Fax |
|
| Email |
shivangi.rana356@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS GORAKHPUR |
| Address |
Department of Dermatology, AIIMS GORAKHPUR |
| 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 Shiwangi Rana |
Aiims Gorakhpur |
Department of Dermatology, Aiims Gorakhpur
Gorakhpur
UTTAR PRADESH |
8860565443
shivangi.rana356@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| aiims gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B351||Tinea unguium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AMOROLFINE NAIL LAQUER |
Application of Amorolfine nail laquer on the affected nail |
| Intervention |
CO2 laser followed by application of Amorolfine nail laquer |
Total of 6 sittings C02 laser of the affected nail every 3 weekly followed by application of amorolfine nail laquer |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All diagnosed patients of onychomycosis (clinically and mycologically) with
age more than 12 years
2. Patients with distal subungual onychomycosis, white superficial
onychomycosis, max. 40 percent of the nail surface affected.
3. Patients with mild to moderate onychomycosis (with OSI less than equal to 15)
4. Patients who are willing for CO2 lser. |
|
| ExclusionCriteria |
| Details |
1. Patients having localized bacterial infection around the affected nail or
concomitant nail disease that causes nail dystrophy or discoloration such as
psoriasis, lichen planus and atopic dermatitis that may interfere with diagnosis
and treatment.
2. Patients with history of intake of oral antifungal medication within the last 3
months or the use of topical antifungal medication within the last 2 weeks prior
to the laser treatment.
3. Pregnant patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Percentage of nail achieving of CER and MCR at the end of 24 week and its
comparision between the 2 group.
2. Change in OSI from baseline to 24 weeks within both the groups. |
Baseline, 18 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparision of recurrence rate in both the group during 3 month follow up after
completion of CO2 laser treatment.
2. Correlation of improvement in CER & MCR with the fungal species. |
Baseline,24 weeks, 36 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/07/2025 |
| 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
|
As per the S1 guidelines for onychomycosis, current management option for mild to moderate onychomycosis are topical antifungal.The main drawback with these drugs are longer treatment duration and poor efficacy, CO2 laser may contribute to inhibiting fungal growth by causing vaporization and exfoliation of the local tissue around the affected nail. This process leads to diffuse remodeling and simultaneously destroys the fungal growth environment. Addition of CO2 laser with conventional topical antifungal may improve clinical efficacy rate, decreases the duration of treatment and chances of replase. |