| CTRI Number |
CTRI/2025/06/089882 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study of different patterns in participants with fungal infection using a dermoscope before and after one month of intervention with antifungal agents. |
|
Scientific Title of Study
|
Study of dermoscopic patterns in pityriasis versicolor before and after one month of antifungal treatment- A one year hospital based longitudinal study at tertiary care hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Antara Raghuwanshi |
| Designation |
Junior resident |
| Affiliation |
KLE University |
| Address |
Department of dermatology,venerology and leprosy, JNMC, KLE,
Belagavi,
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
7218001395 |
| Fax |
|
| Email |
antara10raghuwanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Sajjan |
| Designation |
Assosiate Professor |
| Affiliation |
KLE University |
| Address |
Department of dermatology,venerology and leprosy, JNMC, KLE,
Belagavi,
KARNATAKA
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9880503069 |
| Fax |
|
| Email |
vijaya_sajjan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaya Sajjan |
| Designation |
Assosiate Professor |
| Affiliation |
KLE University |
| Address |
Department of dermatology,venerology and leprosy, JNMC, KLE,
Belagavi,
KARNATAKA
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9880503069 |
| Fax |
|
| Email |
vijaya_sajjan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor, Skin OPD 23, Dr Prabhakar kore hospital,Jawaharlal Nehru medical college, Belgaum, 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Antara Raghuwanshi |
| Address |
Department of dermatology,venerology and leprosy, JNMC, KLE,Belagavi 590010 |
| 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 Antara Raghuwanshi |
KLEs Dr Prabhakar kore hospital |
2nd floor, Skin OPD 23,
Room number 2
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
7218001395
antara10raghuwanshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Oral fluconazole and topical oxiconazole nitrate cream |
Tab fluconazole 400mg stat
Oxiconazole nitrate 1% cream |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient age group of 18-70 years of clinically diagnosed cases of Pityriasis versicolor attending KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi will be recruited. |
|
| ExclusionCriteria |
| Details |
Non consenting patients, All the individuals who were on treatment for the last 1 month, Immunocompromised patients, patients on warfarin, statins, phenytoin, sodium valproate and doxepin. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the dermoscopic parameters like scaling and erythema |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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 4 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pityriasis versicolor is a recurring superficial fungal infection which is usually asymptomatic however can be cosmetically distressing to the patients. Dermoscopic in this condition is still an unexplored area with very little data reported. Because of high recurrence rate in pityriasis versicolor, studying different patterns in it can provide insights into whether the person has recovered from the disease or requires further treatment. |