A clinical study to study the effects of a cream containing a fixed -dose of Halobetasol propionate and Fusidic acid in patients with infected dermatoses

ASSESSMENT OF EFFICACY, SAFETY AND TOLERABILITY OF FIXED DOSE COMBINATION OF HALOBETASOL 0.05% PLUS FUSIDIC ACID 2% CREAM IN PATIENTS WITH INFECTED DERMATOSES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000482

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: Halobetasol 0.05% + Fusidic acid 2%Cream: To be applied twice daily as a thin film and rubbed in gently and copletely with a gap of 12 hours between each application. Control Interventi

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 halobetasol or Clobetasol or salicylic acid or ointment base. Immunocompromised 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 examinationTimepoint: Baseline and Days 8-10;CHANGES IN MEAN SCORE OF CLINICAL SIGNS AND SYMPTOMS AFTER THE TREATMENTTimepoint: Baseline, 4-6 days and 8-10 days;CHANGES IN MEAN TOTAL SCORE OF SIGNS/SYMPTOMS AFTER THE TREATMENTTimepoint: Baseline, 4-6 days and 8-10 days	—

Secondary

Measure	Time frame
GLOBAL ASSESSMENT OF EFFICACY OF TREATMENT BY PHYSICIANS AND PATIENTS RESPECTIVELY Timepoint: Day 8-10	—

Countries

India

Contacts

Public ContactDr Chandrashekhar S Bolmall

chandrashekharb@glenmarkpharma.com022-40189999

Outcome results