Topical Liposomal Amphotericin B Gel Treatment for Cutane... | NCT02656797

Studies
Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

NCT02656797

Sponsor

Soroka University Medical Center

Status

Completed

Last Update Posted

Mar 15, 2022Actual

Enrollment

13Actual

Phase

Phase 2

Conditions

Leishmaniasis

Interventions

Topical Amphotericin-B 0.4% liposomal gel

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2018Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Oct 1, 2021Actual

First Submitted Date

Jan 13, 2016

First Submission Date that Met QC Criteria

Jan 13, 2016

First Posted Date

Jan 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2022

Last Update Posted Date

Mar 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

AMIR HOREV, Head, Pediatric dermatology Service, Soroka University Medical Center, Soroka University Medical CenterPrincipal Investigator

Lead Sponsor

Soroka University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.

Detailed Description

Randomized, double blind, placebo controlled study. The study will include 108 patients with cutenous leishmaniasis of Leishmania species major and tropica, confired by Polymerase Chain Reaction of a sample from a lesion.

Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AM-B	Experimental	Topical Amphotericin-B 0.4% liposomal gel	Drug: Topical Amphotericin-B 0.4% liposomal gel
Placebo	Placebo Comparator	Placebo gel preparation	Drug: Topical Amphotericin-B 0.4% liposomal gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical Amphotericin-B 0.4% liposomal gel	Drug	Topical Amphotericin-B 0.4% liposomal gel	AM-B Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete re-epithelization	Absence of ulceration, induration, erosion and	Day 28 from enrollement

Secondary Outcomes

Measure	Description	Time Frame
Lesion size	Defined by the multiplication of lesion length and width	Day 28 and day 56 from enrollement
Complete re-epithelization		Day 28 from enrollement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cutenous leishmaniasis confirmed by PCR (Leishmania species major or tropica)
1 to 5 lesions
Signed informed consent

Exclusion Criteria:

Facial lesions
Significant co-morbidity
Pregnancy or breast-feeding at enrollment
Previous treatment for leishmaniasis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir Horev, MD	Soroka University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka University Medical Center		Beersheba			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007896	Leishmaniasis

Ancestor Terms

ID	Term
D056986	Euglenozoa Infections
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000666	Amphotericin B

Ancestor Terms

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided