| CTRI Number |
CTRI/2025/09/095502 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomised control experiment comparing the efficacy of combination antifungal cream containing ketoconazole, zinc oxide, transcutol and lactic acid with ketoconazole cream alone for treating fungal infections of skin |
|
Scientific Title of Study
|
Effectiveness of antifungal cream containing two percent ketoconazole, zinc oxide, transcutol and lactic acid vs two percent ketoconazole in the management of treatment naive cutaneous superficial fungal infections A randomized open label control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mridula T |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital, Saveetha institute of medical and technical sciences |
| Address |
Department of Dermatology, Venereology and Leprosy, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9842146455 |
| Fax |
|
| Email |
mithu.krishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abyramy Balasundaram |
| Designation |
Associate Professor |
| Affiliation |
Saveetha medical college and hospital, Saveetha institute of medical and technical sciences |
| Address |
Department of Dermatology, Venereology and Leprosy, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7598566974 |
| Fax |
|
| Email |
b.abyramy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mridula T |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital, Saveetha institute of medical and technical sciences |
| Address |
Department of Dermatology, Venereology and Leprosy, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9842146455 |
| Fax |
|
| Email |
mithu.krishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai- 602105 |
|
|
Primary Sponsor
|
| Name |
Mridula T |
| Address |
Department of Dermatology, Venereology and Leprosy, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai- 602105 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Mridula T |
Saveetha medical college and hospital |
Department of Dermatology, Venereology and Leprosy, Saveetha medical college and hospital, Saveetha nagar, Thandalam, Chennai, Tamil nadu 602105
Chennai
TAMIL NADU |
9842146455
mithu.krishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B368||Other specified superficial mycoses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% ketoconazole cream |
All patients with cutaneous superficial fungal infections will be recruited and one group will be initiated on topical 2% ketoconazole cream twice daily for a period of 6 weeks |
| Intervention |
Antifungal cream containing 2% ketoconazole, zinc oxide, transcutol and lactic acid |
Another group will be initiated on topical antifungal cream containing 2% ketoconazole, zinc oxide, transcutol and lactic acid twice daily for a period of 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Consenting participants of age group 18- 65 years with clinically proven treatment naive cutaneous superficial dermatophytosis and tinea versicolor infections with symptoms for at least one week
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women
2. Participants with deep fungal infections or infections affecting the scalp, nails, or mucosal areas
3. Immunocompromised individuals
4. Known allergies or sensitivity to any ingredients in the study formulation
5. Unwilling to comply with study procedures
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall clinical improvement, DSS score and reduction in pruritus, scaling and color in cutaneous superficial fungal infections |
0, 3 and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects, recurrence rates and patient satisfaction will be assessed |
0, 3 and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
13/10/2025 |
| 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="0"
Months="6"
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
|
Superficial fungal infections are among the most common dermatoses in dermatology practice, primarily caused by dermatophytes, yeasts, and molds. Conventional topical antifungals such as azoles and allylamines are effective but are often limited by intolerance, resistance, and side effects. Ketoconazole, a widely used topical antifungal, acts by inhibiting ergosterol synthesis but is associated with irritation and other cutaneous adverse effects. To address these limitations, a novel topical formulation containing 2% ketoconazole combined with zinc oxide, transcutol, and lactic acid has been developed. This multi-component cream aims to enhance antifungal efficacy, reduce side effects, improve skin tolerance, and support barrier repair, thereby providing a cost-effective and well-tolerated treatment option for superficial fungal infections. |