| CTRI Number |
CTRI/2026/02/103999 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of Topical Luliconazole Versus Salicylic Acid Peel for Management of Pityriasis Versicolor |
|
Scientific Title of Study
|
A comparative study of topical 1 percent luliconazole cream versus 20 percent salicylic acid peel in the management of pityriasis versicolor |
| 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 Sarah Rehan Hawai |
| Designation |
Resident |
| Affiliation |
MIMER Medical College and Dr BSTR Hospital Talegaon Dabhade Pune |
| Address |
Department of Dermatology MIMER Medical College and Dr BSTR Hospital Talegaon Dabhade Pune
Pune
MAHARASHTRA
410507
India |
| Phone |
9112498122 |
| Fax |
|
| Email |
sarahhawai01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Snehal Navande |
| Designation |
Associate Professor |
| Affiliation |
MIMER Medical College and Dr BSTR Hospital Talegaon Dabhade Pune |
| Address |
Department of Dermatology MIMER Medical College and Dr BSTR Hospital Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
9593873844 |
| Fax |
|
| Email |
snehalnavande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarah Rehan Hawai |
| Designation |
Resident |
| Affiliation |
MIMER Medical College and Dr BSTR Hospital Talegaon Dabhade Pune |
| Address |
Department of Dermatology MIMER Medical College and Dr BSTR Hospital Talegaon Dabhade Pune
Pune
MAHARASHTRA
410507
India |
| Phone |
9112498122 |
| Fax |
|
| Email |
sarahhawai01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Snehal Navande |
| Address |
Department of Dermatology MIMER Medical College and Dr BSTR Hospital Talegaon Dabhade Pune |
| 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 Sarah Rehan Hawai |
MIMER Medical College and Dr BSTR Hospital Talegaon Dabhade |
Room number 30 OPD number 31 Department of Dermatology
Pune
MAHARASHTRA |
9112498122
sarahhawai01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MIMER Medical College IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B360||Pityriasis versicolor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1% luliconazole cream |
1% Luliconazole cream twice daily application on left side (depending on site involved) by patient |
| Intervention |
Salicylic acid 20% peel |
Salicylic acid 20% peel was applied on right side/ right half (depending on the site involved). The maximum quantity of salicylic acid peel that was used during a single treatment session was 4ml (0.8 grams of salicylic acid), for upto 3 sessions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients coming to dermatology OPD with lesions of pityriasis versicolor |
|
| ExclusionCriteria |
| Details |
1 Children below the age of 12 years
2 Any previous history of topical application or previous treatment taken
3 Pregnant and lactating female
4 Patients on any systemic and topical antifungal treatment
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of lesions achieving mycological clearance (KOH negativity) at 6 weeks after treatment initiation. |
6 weeks (after completion of 3 follow-ups) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="39" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/02/2026 |
| Date of Study Completion (India) |
14/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pityriasis versicolor is a common superficial fungal infection caused by Malassezia species, characterized by hypopigmented or hyperpigmented scaly patches over the trunk and proximal extremities. Topical antifungals remain the mainstay of treatment; however, recurrence and incomplete clearance are frequent. This prospective, comparative interventional study aims to evaluate and compare the clinical and mycological efficacy of topical 1% luliconazole versus topical 20% salicylic acid peel in patients with pityriasis versicolor involving the body. Eligible patients will be allocated into two treatment groups and followed up at predefined intervals. Clinical assessment will be done using a standardized clinical severity scoring system, and mycological assessment will be performed using potassium hydroxide (KOH) mount examination. The primary outcome will be mycological clearance, defined as negative KOH mount at the end of treatment. The study is expected to provide evidence regarding the comparative effectiveness and safety of these commonly used topical treatment modalities in the management of pityriasis versicolor. |