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.

Phase 3

• Conditions: Tinea Infections Associated with Inflammatory Dermatoses

• Registration Number: CTRI/2010/091/000178
• Lead Sponsor: Glenmark Pharmaceuticals Ltd.

Brief Summary

The study is awaiting ethics commiittee approval at some sites

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of the disease assessed in accordance with the clinical scale; Mycologic assessment;Physician	Baseline, Days 7, 14 and 28

Secondary Outcome Measures

Name	Time	Method
Global assessment of clinical response; Overall response at 4 week	End of study

Trial Locations

Locations (6)

B.J.Medical College & Civil Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Gandhi Medical College & Gandhi Hospital; 🇮🇳 Dept., India

GMC & Sir JJ Group of Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

LTMMedical College & LT Memorial General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Madras Medical College; 🇮🇳 Chennai, TAMIL NADU, India

Seth G S Medical College & KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

B.J.Medical College & Civil Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr. Bela J.Shah

Principal investigator

09898059289

shah.drbela@gmail.com