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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01176994
First received: August 5, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Skin Abnormality
Device: Formulations for in-vivo fixation
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Infiltration of formulations into skin lesions.

  • Safety of formulations [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Formulation ingredients:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with skin lesions that are not treated with histology

Exclusion Criteria:

  • Seriously ill patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176994

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Michael Kahana, MD    972-4-630-4667    kahanam@hy.health.gov.il   
Contact       ezrar@bezeqint.net   
Principal Investigator: Michael Kahana, MD         
Sub-Investigator: Rafael Ezra, MSc Pharm         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Michael Kahana, MD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01176994     History of Changes
Other Study ID Numbers: HYMC-0016-09
Study First Received: August 5, 2010
Last Updated: August 5, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation.

Additional relevant MeSH terms:
Congenital Abnormalities
Skin Abnormalities
Skin Diseases
Formaldehyde
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014