Health Condition 1: B379- Candidiasis, unspecified
Conditions
Interventions
Intervention1: Amfy® gel (Lipid Based Amphotericin B Gel 0.1%: The affected area should be cleaned and dried prior to the application. The IMP
should be applied gently on the affected area twice in
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient or patientâ??s Legally Acceptable representative (LAR) or impartial witness willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedure 2. Patient will be clinically or mycologically diagnosed for Cutaneous and/or Mucocutaneous fungal infection OR HIV infected patients with Cutaneous and/or Mucocutaneous fungal nfection OR Any patient with recurrent Cutaneous and/or Mucocutaneous fungal infection (Recurrent fungal infection is defined as more than 04 episodes annually) 3. Sexually active women, unless surgically sterile (at least 6 months prior to Study treatment) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy for at least 4 weeks prior to study treatment, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician 4. In case of Male patients: Either partner or patient must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last application of study drug. Cessation of birth control after this point should be discussed with a responsible physician
Exclusion criteria
Exclusion criteria: 1. Known case of Hypersensitivity to Amphotericin B 2. Patients using any other topical antifungal therapy at the same time 3. Pregnant or breastfeeding or planning to become pregnant during the study period 4. Diagnosed with disseminated Candidiasis or requires systemic antifungal therapy 5. History of intolerance (e.g., elevation of liver enzymes) to Amphotericin B 6. Has received any systemic antifungal therapy within fourteen (14) days and topical antifungal therapy within 7 days prior to screening 7. Has received any other investigational medicinal therapy within 30 days prior to screening 8. Diagnosed with any concomitant condition that, in the opinion of the investigator, could interfere with the evaluation of efficacy or safety, or would make it unlikely that the subject would complete the study 9. Women with vaginal Trichomonas infection or clue cells of Gardnerella vaginalis vaginitis, Chlamydial infection and venereal diseases would be excluded 10. Patients with Vulvo vaginal candidiasis, who are in menstruation period or expecting menses during the treatment period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Based on the evaluation of clinical efficacy, the primary end point will be evaluated for different indications. Assessment of the primary end point will be totally based on investigatorâ??s judgement. Clinical efficacy will be defined as Cure, Marked improvement, Moderate improvement, Failure or Unassessable. Mycological efficacy will be defined as Eradication, Persistence, Relapse, Super infection or Unassessable.Timepoint: Clinical score will be assessed at all visits, weekly once till the end of the study. Patients of Cutaneous fungal infection will be assessed weekly once from screening visit to visit 4 (day14) or at end of the study visit and patients of Mucocutaneous infection will be assessed from the screening visit to visit 3 (day 7) or at the end of the study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient reported adverse events (serious and non serious events) occurred during the study period. 2. Patientâ??s assessment score (1, 2, 3, 4 or 5) as per a questionnaire provided to patientTimepoint: Patientâ??s assessment will be done daily till the end of the study | — |
Countries
India
Contacts
Public ContactDr Praveen Shetty
Lambda Therapeutic Research Ltd.
Outcome results
None listed