To compare effectiveness, safety and tolerability of Lulican shampoo versus ketoconazole shampoo, in patients having scalp dermatitis.

Not Applicable

Not yet recruiting

• Conditions: Seborrhea capitis,

• Registration Number: CTRI/2021/09/036865
• Lead Sponsor: Anisha Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.
• Patients known to be allergic to the any of the components of the study medications.
• Use of any topical medication including OTC products for dandruff within 14 days of enrolment.
• Patients who are receiving drugs which are known to affect scalp or hair.
• Patients with known malignancy.
• Refusal to participate in the study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Anisha Clinic,; 🇮🇳 Mumbai, MAHARASHTRA, India

Rajiv Gandhi Medical College & CSM Hospital; 🇮🇳 Thane, MAHARASHTRA, India

South Mumbai Dermatology; 🇮🇳 Mumbai, MAHARASHTRA, India

Anisha Clinic,

🇮🇳Mumbai, MAHARASHTRA, India

Dr Shrichand Parasramani

Principal investigator

9821034842

sparasramani@hotmail.com