| CTRI Number |
CTRI/2021/09/036865 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
24/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effectiveness, safety and tolerability of Lulican shampoo versus ketoconazole shampoo, in patients having scalp dermatitis. |
|
Scientific Title of Study
|
Prospective, randomized multi-centre, study to compare the effectiveness, safety and tolerability of Lulican shampoo versus ketoconazole shampoo, in Indian adult patients with mild to moderate scalp Seborrheic Dermatitis (LEAD Study). |
| Trial Acronym |
LEAD Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIl |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrichand G Parasramani |
| Designation |
Consultant Dermatologist |
| Affiliation |
Anisha Clinic |
| Address |
Anisha Clinic, Department of Dermatology, Mangal Sudha, Swami Vivekananda Rd, Khar, Shiv Kutir, Khar West, Mumbai, Maharashtra 400052
Mumbai
MAHARASHTRA
400052
India |
| Phone |
9821034842 |
| Fax |
|
| Email |
shrichandparasramani36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrichand G Parasramani |
| Designation |
Consultant Dermatologist |
| Affiliation |
Anisha Clinic |
| Address |
Anisha Clinic, Department of Dermatology, Mangal Sudha, Swami Vivekananda Rd, Khar, Shiv Kutir, Khar West, Mumbai, Maharashtra 400052
Mumbai
MAHARASHTRA
400052
India |
| Phone |
9821034842 |
| Fax |
|
| Email |
shrichandparasramani36@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrichand G Parasramani |
| Designation |
Consultant Dermatologist |
| Affiliation |
Anisha Clinic |
| Address |
Anisha Clinic, Department of Dermatology, Mangal Sudha, Swami Vivekananda Rd, Khar, Shiv Kutir, Khar West, Mumbai, Maharashtra 400052
Mumbai
MAHARASHTRA
400052
India |
| Phone |
9821034842 |
| Fax |
|
| Email |
shrichandparasramani36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Limited Glenmark House BD Sawant Marg Andheri East Mumbai
400099 |
|
|
Primary Sponsor
|
| Name |
Anisha Clinic |
| Address |
Mangal Sudha, Swami Vivekananda Rd, Khar, Shiv Kutir, Khar West, Mumbai, Maharashtra 400052 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrichand Parasramani |
Anisha Clinic, |
Manga Sudha, SV Road Khar, Mumbai – 400052
Mumbai
MAHARASHTRA |
9821034842
sparasramani@hotmail.com |
| Dr Vishalakshi Viswanath |
Rajiv Gandhi Medical College & CSM Hospital |
Rajiv Gandhi Medical College, Thane
Muncipal Corporation
Belapur Road, Kalwa West, Budhaji Nagar,
Kalwa, Thane, Maharashtra 400605
Thane
MAHARASHTRA |
09324086679
visha1967@gmail.com |
| Dr Deepti Ghia |
South Mumbai Dermatology |
G-44, Department of Dermatology, Roon no 44, Panchshil Plaza, Hugnes Road, Mumbai - 400007
Mumbai
MAHARASHTRA |
9892758778
deepti.ghia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksha- Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L210||Seborrhea capitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Lulican Shampoo |
Group A - 36 thrice weekly application |
| Comparator Agent |
Group B - ketoconazole shampoo |
Group B - 36 thrice weekly application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (18-65 yrs) diagnosed with scalp seborrheic dermatitis and candidates for shampoo therapy at the discretion by treating physician
2. Willing to use shampoo thrice a week as advised
3. Willing to avoid oil application for study duration
4. Patients willing to refrain from other forms of treatment including other topical, oral medication for seborrheic dermatitis
5. Patients who are willing to appear for regular follow ups and follow the prescribed treatment regularly
6. Patients who are willing to give consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Pregnant/ Planning to conceive/ Lactating women
2. Immunocompromised patients on corticosteroids, other immunosuppressive or biologic drugs
3. Patients suffering from infectious, auto-immune, or other disorders affecting skin of scalp.
4. Documented and known history of severe systemic disease, necessitating medical treatment, as assessed by the investigator that might interfere with the conduct of the study or the interpretation of results.
5. Patients known to be allergic to the any of the components of the study medications.
6. Use of any topical medication including OTC products for dandruff within 14 days of enrolment.
7. Patients who are receiving drugs which are known to affect scalp or hair.
8. Patients with known malignancy.
9. Refusal to participate in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Seborrheic Dermatitis Severity Score in both the groups at the end of 4 weeks treatment. |
Time frame – at end 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Evaluation of tolerability and cosmetic acceptability at the end of study
2. Number of participants with any Adverse Event (AE) in both the groups
3. Improvement by PGA in both groups
4. Comparison of mean Scalpdex-23 scores in the both the groups |
1 Time frame – 4 weeks
2 Time frame – up to 4 weeks
3 Time frame – 4 weeks
4 4 weeks compared to baseline |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/10/2021 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, open label, randomized clinical trial has been planned in order to compare the effectiveness, safety and tolerability of Lulican (Luliconazole 1%+ Salicylic acid 3% + ZPTO 1%) vs. ketoconazole (ketoconazole 2%+ZPTO 1%) shampoo in Indian adult patients with mild to moderate scalp seborrheic dermatitis. Eligible patients will be enrolled in the study. The decision to prescribe shampoo, will be made by the treating physician based on prescribing information as per clinical judgement. Treatment will be self-applied thrice weekly for 4 weeks.
The patients will be randomized into two groups (A and B). Patients of group A will be prescribed Lulican shampoo while patients of group B will be prescribed 1% ketoconazole shampoo. All patients will apply shampoo 3 times a week for 4 weeks. Patient will be advised to visit after 2 days of head wash.
Effectiveness will be assessed at week 2 and end of treatment and will be compared to parameters recorded at baseline. |