| CTRI Number |
CTRI/2025/04/085721 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of Nixoderm Tube for treating tinea corporis in adult individuals. |
|
Scientific Title of Study
|
A prospective, randomized, double blind, two arm, comparative clinical study to
evaluate the safety and efficacy of Nixoderm tube in tinea corporis infection in adult subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/RW/NTB/2024 Version: 1.0 Date: 28th October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
RADIANT RESEARCH SERVICES PVT LTD.
Plot No: 99/A, 8th Main Road,
III Phase, Peenya Industrial Area, Bengaluru - 560058,
Karnataka, India
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
RADIANT RESEARCH SERVICES PVT LTD.
Plot No: 99/A, 8th Main Road,
III Phase, Peenya Industrial Area, Bengaluru - 560058,
Karnataka, India
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
RADIANT RESEARCH SERVICES PVT LTD.
Plot No: 99/A, 8th Main Road,
III Phase, Peenya Industrial Area, Bengaluru - 560058,
Karnataka, India
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/s.SC Johnson & Son Nigeria Ltd 13/14 ABIMBOLA STREET, ISOLO LAGOS NIGERIA |
|
|
Primary Sponsor
|
| Name |
MsSC Johnson Son Nigeria Ltd |
| Address |
13/14 ABIMBOLA STREET, ISOLO LAGOS NIGERIA. |
| Type of Sponsor |
Other [[Cosmetic Industry]] |
|
|
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 Abhineetha Hosthota |
The Oxford Medical College ,Hospital & Research Centre |
Department of Dermatology, Yadavanahalli, Attibele, Behind the La Classic Hotel,
Bangalore-562107
Bangalore
KARNATAKA |
9844855574
abhineethahosthota@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford Medical College Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B99||Other and unspecified infectious diseases, (2) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nixoderm tube |
Product to be applied twice a day at the site of infected area, duration 30 days
Dosage form: Cream (Topical application) |
| Comparator Agent |
Placebo |
Product to be applied twice a day at the site of infected area, duration-30days.
Dosage form: Cream (Topical application) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female participants
2. Aged between 18-65 years.
3. Diagnosed with tenia corporis infection
4. Willing to give Informed Consent.
5. Willing to complete the study assessments/questionnaires.
6. Willing to avoid usage of his/her own skin care products in controlling tenia
corporis infection for at least one week before the commencement and during
this study. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or breast feeding.
2. Participants with the history of hypersensitivity to skin care products.
3. Participants with mild to severe anaphylaxis reaction.
4. Participants with pre-existing severe systemic disease necessitating long
term medication.
5. Participants with any other concomitant skin diseases such as psoriasis, eczema
etc
6. Evidence of significant uncontrolled co-morbid disease which in the
investigators opinion would jeopardize patient participation.
7. History of cancer, including solid tumors, hematologic malignancies and
carcinoma in situ.
8. Participation in the current or previous clinical trial with any approved or
investigational products during the past 1 month. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Percentage reduction in ringworm infection from baseline to all
study visits to be evaluated by following parameters:
1.KOH preparation of fungus
2.Dermatological Assessments
3.Percentage reduction in itching and scaling from baseline to all
study visits by Visual Analogue Scores. |
Screening, Day 15, and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The safety of Nixoderm tube in tenia corporis infection from
baseline to all study visits is determined by evaluating adverse events |
Day 0, Day 15 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2025 |
| Date of Study Completion (India) |
16/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Tinea corporis is a superficial fungal skin infection of the body caused by dermatophytes. Tinea corporis is present worldwide. It is defined explicitly by the location of the lesions that may involve the trunk, neck, arms, and legs. Alternative names exist for dermatophyte infections that affect the other areas of the body. These include the scalp (tinea capitis), the face (tinea faciei), hands (tinea manuum), the groin (tinea cruris), and feet (tinea pedis). The dermatophyte’s ability to attach to the keratinized tissue of skin forms the basis for the dermatophytoses (superficial fungal skin infections). The dermatophytes causing tinea corporis belong to genera Trichophyton, Epidermophyton, and Microsporum. Trichophyton rubrum is the most common species to cause dermatophyte infections in the last 70 years. T. Rubrum accounts for 80 to 90% of the strains. Other common isolates include Trichophyton mentagrophytes and Microsporum audouinii. Infection typically occurs with direct contact with the skin from the soil, animals, or the skin of other humans. 1,2 Tinea corporis is exceedingly common worldwide. Dermatophytes are the most prevalent agents of superficial fungal infections. Excessive heat, high relative humidity, and fitted clothing have correlations to more severe and frequent disease.3 The lifetime risk of acquiring tinea corporis is estimated to be 10–20%. Tinea corporis occurs most frequently in post-pubertal children and young adults |