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

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). - LEAD Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036865
Enrollment
72
Registered
2021-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L210- Seborrhea capitis

Interventions

Intervention1: Group A - Lulican Shampoo: Group A - 36 thrice weekly application Control Intervention1: Group B - ketoconazole shampoo: Group B - 36 thrice weekly application

Sponsors

Anisha Clinic
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Reduction in Seborrheic Dermatitis Severity Score in both the groups at the end of 4 weeks treatment.Timepoint: Time frame â?? at end 4 weeks

Secondary

MeasureTime frame
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 groupsTimepoint: 1 Time frame â?? 4 weeks 2 Time frame â?? up to 4 weeks 3 Time frame â?? 4 weeks 4 4 weeks compared to baseline

Countries

India

Contacts

Public ContactDr Shrichand G Parasramani

Anisha Clinic

shrichandparasramani36@gmail.com9821034842

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026