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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03686397
Other study ID # CLEAR-2
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 9, 2020
Est. completion date October 19, 2021

Study information

Verified date November 2022
Source Salvat
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.


Recruitment information / eligibility

Status Completed
Enrollment 194
Est. completion date October 19, 2021
Est. primary completion date October 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Main Inclusion Criteria: - At least 18 years of age - Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated. - Signs/symptoms of pruritus, otalgia and ear fullness. - Debris or drainage clinically consistent with fungal infection. Main Exclusion Criteria: - Known bacterial otitis externa or malignant otitis externa. - Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery. - Structural ear anomalies which may difficult the evaluation of the therapeutic response. - Uncontrolled diabetes mellitus. - Any infection requiring systemic antimicrobial or systemic antifungal therapy. - Concomitant medicines that may interfere with the study evaluations.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SVT-15652
1 vial twice daily
Placebo
1 vial twice daily

Locations

Country Name City State
Spain Hospital Clinic Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Salvat

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic Cure (Clinical and Mycological Cure) Percentage of subjects with therapeutic cure Test of cure on day 24
See also
  Status Clinical Trial Phase
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Completed NCT01547221 - Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients N/A
Recruiting NCT05660382 - Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis Phase 3
Not yet recruiting NCT06431542 - Efficacy of Self vs. Physician Application of Triamcinolone-Econazole in Otomycosis Phase 4
Completed NCT06339294 - Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment Phase 1
Not yet recruiting NCT04824261 - Effectiveness of 4% Boric Acid in Distilled Water Versus Clotrimazole Solution in Otomycosis Patients. N/A
Completed NCT04432376 - Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis) Phase 2/Phase 3
Completed NCT03686384 - SVT-15652 Otic Solution for the Treatment of Otomycosis Phase 3
Completed NCT04768829 - Antifungal Potential of Moringa Olifera Against Otomycosis Early Phase 1
Completed NCT03130738 - Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis Phase 2