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Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.

Primary Purpose

Skin Abnormality

Status
Unknown status
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Formulations for in-vivo fixation
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Skin Abnormality focused on measuring Patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with skin lesions that are not treated with histology

Exclusion Criteria:

  • Seriously ill patients

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skin lesions

Arm Description

Individuals with skin lesions whose lesions are not sent for histology by dermatologists

Outcomes

Primary Outcome Measures

Safety
Infiltration of formulations into skin lesions.
Safety of formulations
Infiltration of the formulations into skin lesions with resultant in-vivo fixation and the achievement of histological result. Possible local pain, infection and scarring will be evaluated.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2010
Last Updated
August 5, 2010
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01176994
Brief Title
Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
Official Title
Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Existing methods of diagnosing and treating skin lesions are either surgical, which enables an histological diagnosis or destructive (electrodesiccation, liquid nitrogen, laser, caustics) with no possibility of obtaining histology. The ingredients of current formulations for in-vivo skin fixation (Mohs, Solcoderm) are unstable, inconvenient for application and painful - therefore their use was abandoned. The investigators will examine the safety of stable formalin-free formulations for in-vivo fixation of human skin lesions .These formulations were safe and had a rapid onset of fixation effect in in-vivo animal studies.
Detailed Description
The formulations are comprised of standard non-toxic laboratory chemicals that are used in various dermatological preparations. Transition metal salts - Zinc chloride, zinc bromide, zinc iodide,zinc nitrate, zinc sulphate. copper chloride ,copper bromide, copper iodide, copper nitrate, copper sulphate. Keratolytics - salicylic acid , lactic acid, nitric acid, pyruvic acid,oxalic acid, trichloro acetic acid, phenol, resorcinol,urea . The solvents and penetration enhancers of the ingredients - Water, ethanol, dimethyl sulfoxide, propylene glycol, glycerol. Patients with skin lesions that after clinical diagnosis are usually treated by dermatologists with destructive modalities without an histological evaluation will be included in the study. The clinical diagnoses include viral warts, seborrheic warts, skin tags, solar keratoses, fibromata and hemangiomata. The treated lesions will be located on the trunk and limbs. Lesions on the face will not be included in the study. The formulations will be infiltrated intra-dermally into the lesions in a maximal volume not exceeding 0.05 ml. After the achievement of the desired local fixation effect, the lesions will be examined by a pathologist. The patients will be closely followed-up during the procedure and the degree of possible associated pain will be evaluated. Possible local infection and the degree of scarring will be evaluated until complete healing of the treated area will occur. The histological result will be informed to the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Abnormality
Keywords
Patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skin lesions
Arm Type
Experimental
Arm Description
Individuals with skin lesions whose lesions are not sent for histology by dermatologists
Intervention Type
Device
Intervention Name(s)
Formulations for in-vivo fixation
Other Intervention Name(s)
Formulation ingredients:
Intervention Description
Formulations are comprised of non-toxic ingredients used in dermatology.
Primary Outcome Measure Information:
Title
Safety
Description
Infiltration of formulations into skin lesions.
Time Frame
One year
Title
Safety of formulations
Description
Infiltration of the formulations into skin lesions with resultant in-vivo fixation and the achievement of histological result. Possible local pain, infection and scarring will be evaluated.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with skin lesions that are not treated with histology Exclusion Criteria: Seriously ill patients
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kahana, MD
Phone
972-4-630-4667
Email
kahanam@hy.health.gov.il
Email
ezrar@bezeqint.net
First Name & Middle Initial & Last Name & Degree
Michael Kahana, MD
First Name & Middle Initial & Last Name & Degree
Rafael Ezra, MSc Pharm

12. IPD Sharing Statement

Learn more about this trial

Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.

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