A Clinical Trial to study the effects of a fixed dose cream formulation of Mometasone 0.1% +Fusidic acid 2% in patients with steroid responsive dermatoses with secondary bacterial infections

ASSESSMENT OF EFFICACY, SAFETY AND TOLERABILITY OF FIXED DOSE COMBINATION OF MOMETASONE 0.1% + FUSIDIC ACID 2% IN TREATMENT OF PATIENTS WITH CORTICOSTEROID-RESPONSIVE DERMATOSES WITH SECONDARY BACTERIAL INFECTIONS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000483

Enrollment

100

Registered

2010-05-25

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: MOMETASONE 0.1% PLUS FUSIDIC ACID 2% CREAM: Cream to be applied over the affected area/s twice daily as a thin film and rubbed in gently and completely, with each application separated

Eligibility

Inclusion criteria

Inclusion criteria: Male & female (post-menopausal, surgically sterilized or practicing a reliable method of birth control) patients with age ranging from 12 to 65 years. Clinical diagnosis of patients with infected dermatoses Written informed consent by patient. Patient willing to follow up.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women. Serious skin disorders, dyspigmentation and extensive scarring in the affected areas. Hypersensitivity to Mometasone or Fusidic acid or cream base. Immuno-compromised states and patients with systemic infections. Patients who have participated in a new drug study in the past 6 months. Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, asthma, collagen disorders, etc. or any other serious medical illness. 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
Bacteriological eradicationTimepoint: Baseline, and Day 13-14;Clinical signs and symptoms, Severity of lesions, discharge from lesions.Timepoint: Baseline, Days 6-7 and Days 13-14	—

Secondary

Measure	Time frame
Global assessment of efficacy of treatment by Physicians and patientsTimepoint: End of the study	—

Countries

India

Contacts

Public ContactDr Chandrashekhar Bolmall

chandrashekharb@glenmarkpharma.com022-40189999

Outcome results