A Study to Find the Effect of Clotrimazole vaginal film

Phase 3

Completed

• Conditions: Noninflammatory disorder of vagina, unspecified,

• Registration Number: CTRI/2022/12/048230
• Lead Sponsor: Hetero Healthcare Limited

Brief Summary

It  is an Open Label, Randomized, Comparative, Parallel, Prospective, Multicentric study. The primary objective of this is to evaluate the clinical efficacy of Clotrimazole Vaginal film as compared to Canesten V6 vaginal tablet in the management of symptomatic vulvovaginal candidiasis in non pregnant women.

The Secondary objective of this trial is to assess the safety of Clotrimazole vaginal film as compared to Canesten V6 vaginal tablet in the management of symptomatic vulvovaginal candidiasis in non pregnant women. Duration of therapy is 7 days, safety follow up will be conducted up to day 14.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Study Completion: 2023-12-19
• Last Update Posted: 2024-06-02

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Women aged 18 to 45 years with clinical diagnosis of symptomatic vulvovaginal candidiasis.
• Subjects with positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae / pseudo hyphae or budding yeast cells.
• Presence of > 1 vulvovaginal sign (erythema, edema, excoriation), presence of > 1 vulvovaginal symptom (itching / pruritus, irritation in and around vagina, burning); composite severity score of > 6.
• Patients with negative whiff test.
• Patients with vaginal pH < 4.5. 6.
• Agree to abstain from intercourse during the study period.
• Agree not to douche or use any intravaginal products during the study period.
• Willing to report response to treatment as per protocol during the study period.
• Willing to give written informed consent.

Exclusion Criteria

• Post-menopausal women 2.
• Menstruating at diagnosis 3.
• Pregnancy or nursing mothers 4.
• Use of intravaginal pessaries, immune suppressive therapy in the last 2 weeks.
• Presence of another vaginal condition, cervical cancer.
• H/O hypersensitivity to study medication, serious illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Proportion of patients with clinical cure - defined as complete resolution of signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.	Day 3,7,14
- Proportion of patients with mycological cure – negative potassium hydroxide (KOH) wet mount from vaginal smear for filamentous hyphae / pseudo hyphae or budding yeast cells at the end of day 7 in each treatment group.	Day 3,7,14
- Proportion of patients with Therapeutic cure – defined as clinical and mycological cure at end of day 7 in each treatment group.	Day 3,7,14

Secondary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events	Day 3, 7, 14

Trial Locations

Locations (10)

All India Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

Cama and Albless Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Hassan Institute of Medical Sciences; 🇮🇳 Hassan, KARNATAKA, India

Kurnool Medical college; 🇮🇳 Kurnool, ANDHRA PRADESH, India

Life Point Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Malla Reddy Hospital; 🇮🇳 Hyderabad, TELANGANA, India

MGM Medical College and Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Modern Government Maternity Hospital; 🇮🇳 Hyderabad, TELANGANA, India

NRS Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Vani Vilas Hospital; 🇮🇳 Bangalore, KARNATAKA, India

All India Institute of Medical Sciences

🇮🇳Khordha, ORISSA, India

Dr Pruthwiraj Sethi

Principal investigator

9438884132

pruthwiaiims@gmail.com