a clinical trial to study the effects of two drugs, butoconazole and clotrimazole in patients with vulvovaginal candidiasis.

Evaluation of efficacy and safety of butoconazole versus clotrimazole in the treatment of vulvovaginal candidiasis: a randomized, open label, active controlled, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000120

Enrollment

200

Registered

2010-02-09

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: Butoconazole vaginal cream 2%: Three days treatment Control Intervention1: Clotrimazole vaginal gel 2%: Six days treatment

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients aged between 18 and 65 years. 2. Has a primary diagnosis of vulvovaginal candidiasis. 3. Patient willing to give their informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2. Patients with vaginal trichomonas infection or clue cells of Gardnerella vaginalis vaginitis. 3. Patients having history of recurrent vulvovaginal candidiasis, defined as occurrence of four or more than four episodes in the previous 12 months. 4. Patients having hypersensitivity to imidazole derivatives. 5. Patients on the treatment with an oral or intravaginal antifungal medication during a week before enrollment. 6. Patients on therapy with antibiotics, systemic antimycotics, corticosteroids, or immunosuppressive drugs. 7. Menstruating patients or patients expecting menses during treatment period.

Design outcomes

Primary

Measure	Time frame
1. Average change from baseline to end of study in severity score of following sign/symptoms based on four point scale (Appendix-I) 1. Erythema 2. Swelling 3. Excoriation 4. Ulceration 5. Discharge 6. Itching 7. Burning 2. Percentage of patients clinically cured 3. Percentage of patients microbiologically cured 4. Percentage of patients therapeutically cured Timepoint: 1. Day 0, Day 13 and day 35 2. Day 13, Day 35 3. Day 13 4. Day 13	—

Measure

Time frame

1. Average change from baseline to end of study in severity score of following sign/symptoms based on four point scale (Appendix-I) 1. Erythema 2. Swelling 3. Excoriation 4. Ulceration 5. Discharge 6. Itching 7. Burning 2. Percentage of patients clinically cured 3. Percentage of patients microbiologically cured 4. Percentage of patients therapeutically cured Timepoint: 1. Day 0, Day 13 and day 35 2. Day 13, Day 35 3. Day 13 4. Day 13

—

Secondary

Measure	Time frame
1. Average change from baseline to end of study in Clinical Global Impression on Severity (CGI-S) 2. Clinical Global Impression on Improvement (CGI-I) in patients Timepoint: 1. Day 0, Day 13 and day 35 2. Day 13, Day 35	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results