EFFICACY, SAFETY AND TOLERABILITY OF SERTACONAZOLE 2% plus ZINC PYRITHIONE 1% SHAMPOO vs KETOCONAZOLE 2% SHAMPOO IN ADULT PATIENTS WITH DANDRUFF

Phase 3

Completed

• Registration Number: CTRI/2009/091/001079
• Lead Sponsor: Glenmark Pharmaceuticals Ltd. Mumbai, India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Males and non-pregnant females (with negative -human chorionic gonadotropin test). Female patients on adequate contraceptive control.
Age: 18 to 70 years
All newly diagnosed cases of Mild, Moderate or Severe Dandruff and /or Seborrheic dermatitis of the scalp
Patient willing to comply with study procedures and requirements

Exclusion Criteria

Pregnant and nursing women
Patients hypersensitive to any study medications and ingredients
Psoriasis of scalp
Atopic dermatitis
Tinea capitis
Parkinson?s disease, epilepsy, facial nerve paresis, spinal cord disease
Shoulder length or longer hair
Topical treatment of the scalp with other antifungal medication or with corticosteroids in the last 2weeks before start of washout period.
Systemic use of retinoids, erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole or metronidazole within 28 days before start of washout period
Uncontrolled diabetes
Treatment with any other investigational drug in 4 weeks prior to study entry
Immunocompromised states and patients with systemic infections.
Patients with severe cardiac, hepatic, renal, or cerebrovascular disease or malignancy, chronic uncontrolled systemic diseases e.g.,hypertension, collagen disorders, etc. or any other serious medical illness.
History of alcohol abuse
Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary: Improvement in improvement in dandruff score and Improvement in itching and erythema score <br>Timepoint: Visits 1-5

Secondary Outcome Measures

Name	Time	Method
Improvement in Patient?s and Physician?s Global Assessment of dandruff and /or seborrheic dermatitis of the scalp and over all acceptability by patients.Timepoint: Visits 1-5