CTRI/2022/06/043131 [Registered on: 09/06/2022] Trial Registered Prospectively
Last Modified On:
02/12/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to assess the effectiveness and side effects of Naftifine Cream 2% in patients with fungal infection of foot.
Scientific Title of Study
“A Phase III, Prospective, Randomized, Double Blind, Active Controlled, Comparative, Parallel Group and Multicentric Clinical Study to Evaluate the Efficacy and Safety of Naftifine Hydrochloride Cream 2% w/w in the Treatment of Patients with Interdigital Tinea Pedis.â€
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CRPL/CT/21/018, Version No.: 00 & Dated Aug 16, 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar,
Near Ramalayam Temple,
Kukatpally, Hyderabad-500072,
Telangana, India.
Hyderabad TELANGANA 500072 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
# H. No.: 4-32-41/13, Plot No.: 38,
Kamala Prasanna Nagar,
Near Ramalayam Temple,
Kukatpally, Hyderabad-500072,
Telangana, India.
TELANGANA 500072 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Mr Surender Kumar Arora
Designation
President - Drug Regulatory Affairs
Affiliation
Synokem Pharmaceuticals Ltd.
Address
Synokem Pharmaceuticals Ltd.,
14/486, Sunder Vihar,
Outer Ring Road, Paschim Vihar,
New Delhi-110087, India.
New Delhi DELHI 110087 India
Phone
9811015684
Fax
Email
ska@synokempharma.com
Source of Monetary or Material Support
Synokem Pharmaceuticals Ltd.
Primary Sponsor
Name
Synokem Pharmaceuticals Ltd
Address
14/486, Sunder Vihar,
Outer Ring Road,
Paschim Vihar,
New Delhi-110087, India.
Department of Dermatology, Venereology and Leprosy, 578, B.T Road, Kamarhati, Kolkata-700058. Kolkata WEST BENGAL
9007977161
ipodder88@gmail.com
Dr Gurram Narsimha Rao Netha
Gandhi Medical College and Hospital
Department of Dermatology, Venereology and Leprosy (DVL), In Patient Block,
5th Floor, Gandhi Hospital, Musheerabad, Secunderabad-500003. Hyderabad TELANGANA
9390032196
gnrnetha@gmail.com
Dr V Revathi
Government Medical College & Government General Hospital (Old RIMSGGH)
Department of Dermatology, Srikakulam-532001. Srikakulam ANDHRA PRADESH
8942279033
drrevathivggh@gmail.com
Dr Dev Prakash Shivhare
GSVM Medical College
Department of Dermatology, Swaroop Nagar, Kanpur-208002. Kanpur Nagar UTTAR PRADESH
9450136374
derma@gmail.com
Dr Gamit Hemangini Harishbhai
Hope Well Medical Hospital
Research Room, Block G, 1stFloor, 101, 102, Sumel-8, Nr. Ajit Mill Char Rasta, Rakhiyal, Ahmedabad-380023. Ahmadabad GUJARAT
8238935754
hemanginigamit777@gmail.com
Dr Raj Kumar Kothiwala
Jawahar Lal Nehru (J.L.N) Medical College
Department of Dermatology, Kala Bagh, Ajmer-305001. Ajmer RAJASTHAN
Institutional Ethics Committee, Osmania Medical College
Approved
Institutional Ethics Committee, Ruby General Hospital Ltd.
Approved
North East Healthcare Private Limited, W Pratiksha Hospital
Approved
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2)
Approved
Sangini Hospital Ethics Committee, Hope Well Medical Hospital
Approved
Vidhya Hospital and Trauma Centre Ethics Committee, Vidhya Hospitals & Trauma Centre
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: B353||Tinea pedis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Miconazole Nitrate Cream 2% w/w
Patients will be advised to apply a thin layer of cream twice daily (morning and evening) to the affected area plus 1 inch margin of healthy surrounding skin for 14 days.
Patients will be advised to apply a thin layer of cream twice daily (morning and evening) to the affected area plus 1 inch margin of healthy surrounding skin for 14 days.
Morning - Naftifine Hydrochloride Cream 2% w/w
Evening - Placebo Cream
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male and Female Patients aged between 18 to 65 years (both inclusive).
2. Patients with clinical diagnosis of tinea pedis with lesions predominantly localized to the interdigital spaces on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms.
3. Patients with the sum of the clinical signs and symptoms scores of the target lesion is at least 5, including a minimum score of at least 2 for erythema and scaling and 1 for pruritus (on a scale of 0-3, where 2 indicates moderate severity).
4. Patients with mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic 10% Potassium Hydroxide (KOH) wet mount examination.
5. 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.
6. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
7. Patients willing to comply with the protocol requirements.
ExclusionCriteria
Details
1. Patients with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot.
2. Patients with known hypersensitivity to allylamine and/or azole antifungal agents.
3. Patients with clinical laboratory evaluations (hematology, biochemistry and routine urine analysis) are not within the reference range for the testing laboratory or the results are deemed clinically significant by the investigator.
4. Patients with known case of type 1 diabetes and type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
5. Patients with any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
6. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
7. Patients with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
8. Patients using antipruritics, including antihistamines, within 72 hours prior to randomization.
9. Patients using topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to randomization.
10. Patients using systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to randomization.
11. Patients using oral Terbinafine or Itraconazole within 2 months prior to randomization.
12. Patients using immunosuppressive medication or radiation therapy within 3 months prior to randomization.
13. Patients with history of dermatophyte infections unresponsive to systemic or topical antifungal drugs.
14. Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
15. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
16. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
17. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
18. Suspected inability or unwillingness to comply with the study procedures.
19. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients achieving clinical cure at Day 42 (±3 days) / Week 6.
At Day 42
Secondary Outcome
Outcome
TimePoints
Proportion of patients achieving clinical cure at Day 84 (±3 days) / Week 12.
At Day 84
Proportion of patients achieving mycological cure at Day 42 (±3 days) / Week 6 and at Day 84 (±3 days) / Week 12.
At Day 42 & Day 84
Proportion of patients achieving complete clearance at Day 42 (±3 days) / Week 6 and at Day 84 (±3 days) / Week 12.
At Day 42 & Day 84
Adverse events / serious adverse events reported during the study.
Throughout the study
Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).
At Visit 1/Screening Visit, Day 14 and Day 84
Target Sample Size
Total Sample Size="178" Sample Size from India="178" Final Enrollment numbers achieved (Total)= "198" Final Enrollment numbers achieved (India)="198"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
trial is a phase III, prospective, randomized, double blind, active controlled,
comparative, parallel group and multicentric clinical study to evaluate the efficacy
and safety of Naftifine Hydrochloride Cream 2% w/w in the treatment of patients
with interdigital tinea pedis.
Patients
who are willing and able to participate in the study will sign and date the
Informed Consent Form on the day of screening / baseline visit (Visit 1).
During this screening period, patients who are willing to give consent will be
evaluated for all the eligibility criteria. Eligible patients (male or female) aged
between 18 to 65 years (both inclusive), with clinical diagnosis of tinea pedis
with lesions predominantly localized to the interdigital spaces on one or both
feet characterized by clinical evidence of a tinea infection (at least moderate
erythema, moderate scaling, and mild pruritus) based on signs and symptoms will
be considered for the study.
After confirming the inclusion/exclusion criteria the
subject will be randomized and provided with study medication at randomization
visit. Subjects will be provided with patient diary at randomization visit,
which need to be brought along with in each subsequent visit till the last
visit. Follow up visits will be done on week 2/day 14(±3)/End of the treatment,
week 6/day 42(±3) and week 12/day 84(±3)/End of the study.
Patients will be
assigned to either of the two arms i.e., Arm A or Arm B consisting of Naftifine
Hydrochloride Cream 2% w/w & Placebo Cream or Miconazole Nitrate Cream 2%
w/w. Patients will be given the study medication twice a day for 2 weeks.