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CTRI Number  CTRI/2024/03/063840 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To understand activity of formulation containing Lactoferrin cream and Luliconazole cream against Luliconazole Cream alone in treatment of skin fungal infections 
Scientific Title of Study   A Single Center, Randomized, Open-Label, Prospective, Parallel Group Study to Evaluate antifungal and biofilm inhibition activity of formulation containing Lactoferrin cream + Luliconazole cream against Luliconazole Cream in the Treatment of Patients with cutaneous Candidiasis and Dermatophytosis 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dhruv R Patel 
Designation  Consultant Dermatologist 
Affiliation  Namostute Hospital 
Address  Clinical Research Department, Basement, Plot No: 1285, Sector-6-D, Gh-3 Circle,
Opposite Civil Hospital
Gandhinagar
GUJARAT
382006
India 
Phone  8347475738  
Fax    
Email  pateldhruv278278@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dhruv R Patel 
Designation  Consultant Dermatologist 
Affiliation  Namostute Hospital 
Address  Clinical Research Department, Basement, Plot No: 1285, Sector-6-D, Gh-3 Circle,
Opposite Civil Hospital
Gandhinagar
GUJARAT
382006
India 
Phone  8347475738  
Fax    
Email  pateldhruv278278@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rakesh Ray 
Designation  Clinical Research Associate 
Affiliation  RYT Life Sciences 
Address  Clinical Operations Department, Shop No.205/1- Shilp Arcade,
LBS Road, Bapunagar,
Ahmadabad
GUJARAT
380024
India 
Phone  7778866235  
Fax    
Email  rakesh@rytlifesciences.com  
 
Source of Monetary or Material Support  
Dr Dhruv R Patel, Namostute Hospital, Clinical Research Department, Basement, Plot No: 1285, Sector-6-D, Gh-3 Circle, Opposite Civil Hospital, Gandhinagar - 382006, Gujarat 
 
Primary Sponsor  
Name  Frimline Private Limited 
Address  511, Iscon Elegance, Circle P, Near Jain Temple, Prahlad Nagar Cross Roads, S. G. Highway, Ahmedabad – 380015, Gujarat, India 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhruv R Patl  Namostute Hospital  Clinical Research Department, Basement, Plot No: 1285, Sector- 6-D, GH# Circle, Opposite: Civil Hospital Gandhinagar - 382006
Ahmadabad
GUJARAT 		 8347475738

pateldhruv278278@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Shashvat Surgicare Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Lactoferrin Cream + Luliconazole Cream 1% w/w  Dose: Quantity Sufficient Frequency: Once Daily Route of administration: Topical Total duration: From baseline visit and continue for 14 days. 
Comparator Agent  Luliconazole Cream 1% w/w  Dose: Quantity Sufficient Frequency: Once Daily Route of administration: Topical Total duration: From baseline visit and continue for 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients will be included in the study if they meet all the following criteria:
1.Male or female patients aged between 18 to 65 years (both inclusive) with a clinical diagnosis of mycologically proven cutaneous candidiasis or dermatophytosis (Tinea/ Ringworm). Cutaneous candidiasis includes below-
A. Candidial folliculitis
B. Candidal intertrigo
C. Candidal paronychia
D. Perianal candidiasis
E. Candidid
F. Chronic mucocutaneous candidiasis
G. Congenital cutaneous candidiasis
H. Erosio interdigitalis blastomycetica
I. Candidial onychomycosis
Dermatophytosis includes
A. Tinea barbae
B. Tinea capitis
C. Tinea corporis
D. Tinea cruris
E. Tinea pedis
2. Patients with localized superficial fungal infection confirmed by the presence of fungal hyphae in KOH (potassium hydroxide) preparation of skin scrapings from over the lesion at screening visit
3. Patients agree not to use Æ’any other topical product on the affected area during the entire course of study except for non-medicated, investigator-approved cleanser, and sunscreen. Patients should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening/ baseline visit.
5. Patients with the ability to understand and provide a written informed consent form before the screening.
6. Patients willing to comply with the protocol requirements throughout the study.
 
 
ExclusionCriteria 
Details  Patients are excluded from the study if any of the following criteria apply
1. Patients with known or suspected hypersensitivity to quinolone antibacterial agents or azoles for example Ketoconazole.
2. Patients with the presence of any skin condition that would interfere with the diagnosis or assessment of cutaneous candidiasis.
3. Patients receiving treatment with the following products
a. Systemic antifungals for the treatment of cutaneous candidiasis in the 30 days before the baseline visit.
b. Any medication or procedure that, in the opinion of the investigator, would put the Patient at unacceptable risk for participation in the study or may interfere with evaluations in the study.
4. Patients with uncontrolled hypertension with sitting systolic BP 160 mmHg and or diastolic BP100 mmHg at screening.
5. Females who are pregnant or lactating or planning to become pregnant during the study period.
6. Patients with a history of experiencing significant burning or stinging when applying any topical treatment.
7. Patients with a serious and or chronic medical conditions.
8. Patients with a history of substance abuse or dependence that in the opinion of the Investigator considered interfering with the patients participation in the study.
9. Patients with concurrent participation in another clinical trial or any investigational therapy within 90 days before signing informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Lactoferrin cream + Luliconazole cream in inhibiting biofilm formation compared to Luliconazole cream alone in patients suffering from cutaneous candidiasis and dermatophytosis.  Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical efficacy of Lactoferrin cream + Luliconazole cream in resolving cutaneous candidiasis & dermatophytosis, as measured by clinical symptom improvement & mycological cure rates.
To assess the safety & tolerability of Lactoferrin cream + Luliconazole cream compared to Luliconazole cream alone in patients with cutaneous candidiasis & dermatophytosis. 		 Day 14 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 14/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 study is â€œA Single Center, Randomized, Open-Label, Prospective, Parallel Group Study to Evaluate antifungal and biofilm inhibition activity of formulation containing Lactoferrin cream + Luliconazole cream against Luliconazole Cream in the Treatment of Patients with cutaneous Candidiasis and Dermatophytosis”.”  The study will be conducted at a single center in India by a qualified Investigator, in dermatologist. The study will be initiated only after receipt of regulatory and EC.

approval.

Title

"A Single Center, Randomized, Open-Label, Prospective, Parallel Group Study to Evaluate antifungal and biofilm inhibition activity of formulation containing Lactoferrin cream + Luliconazole cream against Luliconazole Cream in the Treatment of Patients with cutaneous Candidiasis and Dermatophytosis”"

Short Title

To Evaluate antifungal and biofilm inhibition activity of formulation containing Lactoferrin cream + Luliconazole cream against Luliconazole Cream in the Treatment of Patients with Cutaneous Candidiasis and Dermatophytosis

Protocol Number: Lf-Af/2023/01

Phase: Pilot phase

 
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