CTRI/2021/09/036865
Not yet recruiting
Phase 4
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
Anisha Clinic0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: L210- Seborrhea capitis
- Sponsor
- Anisha Clinic
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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