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

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.

Study Overview

• Status: Unknown
• Conditions: Skin Abnormality
• Intervention / Treatment: Device: Formulations for in-vivo fixation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
    • Contact: Michael Kahana, MD; Phone Number: 972-4-630-4667; Email: kahanam@hy.health.gov.il
    • Contact: Email: ezrar@bezeqint.net
    • Principal Investigator: Michael Kahana, MD
    • Sub-Investigator: Rafael Ezra, MSc Pharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with skin lesions that are not treated with histology

Exclusion Criteria:

• Seriously ill patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin lesions; Individuals with skin lesions whose lesions are not sent for histology by dermatologists	Device: Formulations for in-vivo fixation; Formulations are comprised of non-toxic ingredients used in dermatology.; Other Names: Formulation ingredients:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Infiltration of formulations into skin lesions.	One year
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.	One year

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 6, 2010

Study Record Updates

• Last Update Posted (Estimate): August 6, 2010
• Last Update Submitted That Met QC Criteria: August 5, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation.
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Skin Abnormalities
• Other Study ID Numbers: HYMC-0016-09