| CTRI Number |
CTRI/2025/10/095558 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FRACTIONAL CO2 LASER and 8% CICLOPIROX NAIL NACQUER] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of CO2 Laser plus Antifungal Nail Lacquer versus Antifungal Nail Lacquer Alone in Treating Fungal Nail Infection |
|
Scientific Title of Study
|
Study of the effectiveness of fractional CO2 laser therapy combined
with 8 percent ciclopirox nail lacquer Vs ciclopirox nail lacquer
alone in Onychomycosis Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankush Kumar Somvanshi |
| Designation |
PG STUDENT |
| Affiliation |
Institute Of Naval Medicine, INHS Asvini |
| Address |
Department Of Dermatology
INHS Asvini
Mumbai
MAHARASHTRA
400005
India |
| Phone |
7066530848 |
| Fax |
|
| Email |
ankushkumar6793@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VEENA KHARAYAT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Institute Of Naval Medicine, INHS Asvini |
| Address |
Department Of Dermatology
INHS Asvini
MAHARASHTRA
400005
India |
| Phone |
8360610643 |
| Fax |
|
| Email |
kharayatveena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankush Kumar Somvanshi |
| Designation |
PG STUDENT |
| Affiliation |
Institute Of Naval Medicine, INHS Asvini |
| Address |
Department Of Dermatology
INHS Asvini
MAHARASHTRA
400005
India |
| Phone |
7066530848 |
| Fax |
|
| Email |
ankushkumar6793@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF DERMATOLOGY,
INHS ASVINI
INSTITUTE OF NAVAL MEDICINE
COLABA
MUMBAI
PIN CODE- 400005
INDIA |
|
|
Primary Sponsor
|
| Name |
Institute of Naval Medicine |
| Address |
DEPARTMENT OF DERMATOLOGY
INHS ASVINI
INSTITUTE OF NAVAL MEDICINE
COLABA
MUMBAI
INDIA
PIN CODE 400005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ankush Kumar Somvanshi |
INHS ASVINI |
Room Number P50010
Department Of Dermatology
INHS Asvini
INHS Asvini
Mumbai
MAHARASHTRA |
70665 30848
ankushkumar6793@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS ASVINI |
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 |
Ciclopirox 8% nail lacquer |
Participants will receive daily topical application of 8% Ciclopirox nail lacquer alone for 24 weeks without laser therapy. |
| Intervention |
Fractional CO2 Laser + Ciclopirox 8% nail lacquer |
Participants will receive Fractional CO2 laser therapy applied to affected nails at baseline, in addition to daily topical application of 8% Ciclopirox nail lacquer for 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Age between 18 to 75 years.
Involvement of two or more fingernails or toenails.
Positive KOH microscopy for fungal elements.
Treatment-naïve patients (no prior antifungal treatment for onychomycosis). |
|
| ExclusionCriteria |
| Details |
Age below 18 years.
Involvement of less than two fingernails or toenails.
Negative KOH mount for fungal elements.
Female subjects who are pregnant, nursing, or planning to become pregnant during the study period.
Presence of other conditions causing nail dystrophy such as psoriasis, eczema, lichen planus, or immunodeficiency states (e.g., HIV infection, post-organ transplantation, long-term immunosuppressive therapy, chemotherapy, or radiotherapy).
Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), or immune systems, or other medical conditions which may interfere with or confound study assessments (e.g., pre-existing chronic foot pain, neurologic deficit, or skin disease/injury of the treated foot). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical cure – improvement in nail appearance, reduction in discoloration and thickness, assessed at 12 weeks and 24 weeks.
Mycological cure – negative KOH microscopy and culture at 12 weeks and 24 weeks. |
12 AND 24 WEEKS POST INITIATION OF TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate patient-reported outcomes including pain, discomfort, and cosmetic
improvement. |
24 WEEKS POST INITIATION OF TREATMENT |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="2"
Months="0"
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
|
This randomized controlled clinical trial is designed to evaluate the effectiveness of Fractional CO2 laser therapy combined with 8 percent Ciclopirox nail lacquer compared to 8 percent Ciclopirox nail lacquer alone in the treatment of onychomycosis. The study hypothesis is that the combination of Fractional CO2 laser therapy with topical Ciclopirox will achieve superior clinical and mycological cure rates compared to topical Ciclopirox alone. Eligible participants will be randomized into two groups. The intervention arm will receive Fractional CO2 laser therapy along with daily application of Ciclopirox 8 percent nail lacquer. The control arm will receive Ciclopirox 8 percent nail lacquer alone. Primary outcomes will include clinical cure and mycological cure assessed at 12 weeks and 24 weeks. Secondary outcomes will include reduction in nail thickness, improvement in nail appearance, patient satisfaction, recurrence rate, and adverse effects. |