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

COMPARATIVE ASSESSMENT OF THE EFFICACY, SAFETY AND TOLERABILITY OF SERTACONAZOLE 2% plus ZINC PYRITHIONE 1% SHAMPOO vs KETOCONAZOLE 2% SHAMPOO IN ADULT PATIENTS WITH DANDRAFF/ SEBORRHEIC DERMATITIS OF THE SCALP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001079

Enrollment

200

Registered

2010-01-05

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

None listed

Interventions

Intervention1: Sertaconazole2% +Zinc pyrithione 1% shampoo: 5ml to be applied twice a week on the scalp and rinsed with warm water Control Intervention1: Ketoconazole 2% shampoo: 5ml applied twice wee

Eligibility

Inclusion criteria

Inclusion criteria: Males and non-pregnant females (with negative &#61538;-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

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.

Design outcomes

Primary

Measure	Time frame
Primary: Improvement in improvement in dandruff score and Improvement in itching and erythema score Timepoint: Visits 1-5	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactChandrashekhar Bolmall

chandrashekharb@glenmarkpharma.com91-22-40189999

Outcome results