A clinical trial to study the effect of a fixed dose formulation of Sertaconazole + Beclomethasone and miconazole nitrate in patients with tinea infections associated with inflammatory skin conditions.

Comparative assessment of efficacy, safety and tolerability of Sertaconazole nitrate 2% plus Beclomethasone dipropionate 0.025% cream vs Miconazole nitrate 2% cream in Patients with Tinea Infections Associated with Inflammatory Dermatoses

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000178

Enrollment

200

Registered

2010-02-23

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: Sertaconazole nitrate 2 % plus Beclomethasone dipropionate 0.025% cream: Every 12 hours topical Control Intervention1: Miconazole nitrate 2% cream: Every 12 hours topical

Eligibility

Inclusion criteria

Inclusion criteria: Male & female (post-menopausal, surgically sterilized or practicing a reliable method of birth control) patients with age ranging from 18 to 70 years;Clinical diagnosis of tinea infections, confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide [KOH] test) with inflammatory dermatoses;Written informed consent by patient; Patient willing to follow up.

Exclusion criteria

Exclusion criteria: Pregnant or lactating women;Patients who had received oral treatment with antimycotics during the 4 weeks preceding the trial or topical treatment during the week before; Patients with compromised immunity (patients taking steroid, immunosuppresants or with HIV/AIDS;Applied topical antifungal therapy to the feet within 14 days of study or had been treated with oral antifungal therapies within 3 months of study entry;Hypersensitivity to Sertaconazole nitrate, beclomethasone dipropionate, miconazole or base of cream; 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
Clinical evaluation of the disease assessed in accordance with the clinical scale; Mycologic assessment;PhysicianTimepoint: Baseline, Days 7, 14 and 28	—

Secondary

Measure	Time frame
Global assessment of clinical response; Overall response at 4 weekTimepoint: End of study	—

Countries

India

Contacts

Public ContactChandrashekhar S Bolmall

Medical Services Department

chandrashekharb@glenmarkpharma.com91-22-40189999

Outcome results