| CTRI Number |
CTRI/2017/11/010661 [Registered on: 27/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
17/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on efficacy of Fractional CO2 Laser( a type of medical laser) along with topical 1% Terbinafine (a topical medicine for fungal infection) in treatment of onychomycosis (fungal infection of nails) |
|
Scientific Title of Study
|
A study of efficacy of Fractional CO2 Laser along with topical 1% Terbinafine in treatment of onychomycosis |
| Trial Acronym |
FRACO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Lal V |
| Designation |
Post Graduate Resident |
| Affiliation |
Command Hospital Air Force |
| Address |
Department of Dermatology
Command Hospital Air Force
Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
9483998640 |
| Fax |
|
| Email |
sandeeplalv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Arora |
| Designation |
Professor |
| Affiliation |
Command Hospital Air Force |
| Address |
Department of Dermatology
Command Hospital Air Force
Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
9483998640 |
| Fax |
|
| Email |
aroraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Lal V |
| Designation |
Post Graduate Resident |
| Affiliation |
Command Hospital Air Force |
| Address |
Department of Dermatology
Command Hospital Air Force
Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
9483998640 |
| Fax |
|
| Email |
sandeeplalv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology
Command Hospital Air Force
Bangalore
Karnataka
560007 |
|
|
Primary Sponsor
|
| Name |
Command Hospital Air Force |
| Address |
Department of Dermatology
Command Hospital Air Force
Bangalore |
| 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 |
| Sandeep Lal V |
Command Hospital Air Force |
Department of Dermatology
Command Hospital Air Force
Bangalore
Bangalore
KARNATAKA |
9483998640
sandeeplalv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with onychomycosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional CO2 Laser and Topical 1% Terbinafine cream |
50 onychomycotic nails, Fractional CO2 Laser would be done at monthly intervals for four months in aptients with onychomycosis. They will apply topical Terbianfine cream also for four months. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females over the age of 18 years
2.Patient with one or more toenail and/or fingernail fungal infections of the following types: distal subungual onychomycosis, proximal subungual onychomycosis, superficial white or black onychomycosis, mixed patterns or total dystrophic type onychomycosis.
3.Confirm diagnosis using fungal culture and direct microscopy
|
|
| ExclusionCriteria |
| Details |
1.Fungal culture negative or no evidence on direct microscopy.
2.Those patients who used systemic or topical antifungal in the past three months of the first scheduled laser session to be excluded.
3.Conditions, like bacterial infections, subungual hematoma, associated nail disorders which produce changes in the nail plate like psoriasis, atopic dermatitis, lichen planus.
4.Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in onychomycosis severity or complete clearance |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete clearance |
Anytime before 4 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2016 |
| Date of Study Completion (India) |
31/08/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/08/2017 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
www.marinemedicalsociety.in › article
Fractional CO2 laser in the management of ... - Journal of Marine Medical Society |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Onychomycosis is fungal infection of the nail apparatus. It can involve either toenails or fingernails. Onychomycosis causes pain, discomfort, and disfigurement and the discolouration of nails which is the most common complaint and may produce serious physical and occupational limitations, as well as affect the quality of life. Present treatment modalities are ineffective in complete clearance or cur of onychomycosis The study aims
· To objectively assess the efficacy and side effect profile of Fractional CO2 laser on patients suffering from onychomycosis · To review published evidence regarding the effectiveness of laser technologies in the treatment of onychomycosis · To formulate guidelines for use of Fractional CO2 laser in onychomycosis if found effective. 1. MATERIAL (a)Study Sample Size - Total sample size is 50 onychomycotic nails of patients presenting with onychomycosis. (b) Study Population - Patients presenting with onychomycosis at dermatology department of Command Hospital Airforce Bangalore during the study period. (c) Place of Study - Department of Dermatology, Command Hospital A Air force Bangalore (d) Period of Study - 01 September 2016 to 31 August 2017. (a) Inclusion
criteria
1. Males
and females over the age of 18 years
2. Patient
with one or more toenail and/or fingernail fungal infections of the following
types: distal subungual onychomycosis, proximal subungual onychomycosis,
superficial white or black onychomycosis, mixed patterns or total dystrophic
type onychomycosis.
3. Confirm
diagnosis using fungal culture and direct microscopy
(b)
Exclusion Criteria
1. Fungal
culture negative or no evidence on direct microscopy.
2. Those
patients who used systemic or topical antifungal in the past three months of
the first scheduled laser session to be excluded.
3. Conditions,
like bacterial infections, subungual hematoma, associated nail disorders which
produce changes in the nail plate like psoriasis, atopic dermatitis, lichen
planus.
4. Pregnant
women.
(c) Informed consent will be taken
from individual participating in the
study.
(d)
All the cases will be assessed clinically for onychomycosis and
objectively scored using ONYCHOMYCOSIS SEVERITY INDEX (OSI) and further will be
confirmed by nail clipping (KOH mount) and mycotic culture.
(e)
Only culture positive cases shall be included in the study.
(f)
Treatment- All the infected nails will be treated with fractional CO2
laser (CIS Fi, SellasLaser Technology Co) using
pulse energy of 110 mJ, a density of 256 spots/cm2,
pulse interval of 0.5 mm, pulse duration of 0.1
milliseconds, and a rectangular spot size of 2- to
10-mm length and 0.6- to 5-mm breadth. These parameters
were chosen after a pilot study in department with
different parameters. 3 passes will be given at the same site in static operating mode over the affected area including 1-mm normal-appearing areas around them. Altogether 4 sessions of laser therapy were given, each at 4-week intervals. Subjective
evaluation of pain using a visual analogue scale was done during each session. The
patients were prescribed Topical 1% Terbinafine cream for application over the
affected nails twice daily during the study period.
(g)
Follow-up shall be performed at each visit at 4 weeks interval with
assessment of clinical improvement using OSI score, photography and patient
subjective assessment sore. After four sessions of LASER treatment in addition
to the above modalities assessment will be done with mycological cultures and
KOH mount. The patient will again be followed up at 6 months from the initial
treatment.
(h)
Adverse effects shall be recorded and all participants will be asked to complete
"subjective assessment score" rating their level of satisfaction.
(j)
Complete cure is accepted as the combination of mycological and clinical
cure.
(k)
Instructions
-Should not apply moisturiser or any anti-fungal cream other than the
prescribed.
-Should not take any oral antifungal
drug.
-Regular follow-up for the treatments
(l)
After the trial period of 16 and 24 weeks, the participating patients
answers the Post- Trial Questionnaire and analysis of the data will be carried
out.
(m)
The data will be maintained prospectively in a computerized database,
along with hard copies of proformas which will be analyzed using appropriate
statistical techniques.
(n)
Side effect, if any due to fractional CO2 laser will be monitored.
(q)
Endpoints of Study: Signs and symptoms like Scaling, erythema, and Vesicular
eruptions, Fissures, itching or burning will be followed up every week for 16
weeks |