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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01176994
Recruitment Status : Unknown
Verified July 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 6, 2010
Last Update Posted : August 6, 2010
Information provided by:
Hillel Yaffe Medical Center

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.

Condition or disease Intervention/treatment Phase
Skin Abnormality Device: Formulations for in-vivo fixation Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
Study Start Date : December 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

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 Name: Formulation ingredients:

Primary Outcome Measures :
  1. Safety [ Time Frame: One year ]
    Infiltration of formulations into skin lesions.

  2. Safety of formulations [ Time Frame: One year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with skin lesions that are not treated with histology

Exclusion Criteria:

  • Seriously ill patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01176994

Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Michael Kahana, MD    972-4-630-4667   
Principal Investigator: Michael Kahana, MD         
Sub-Investigator: Rafael Ezra, MSc Pharm         
Sponsors and Collaborators
Hillel Yaffe Medical Center

Responsible Party: Michael Kahana, MD, Hillel Yaffe Medical Center Identifier: NCT01176994     History of Changes
Other Study ID Numbers: HYMC-0016-09
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: July 2010

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:
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Anti-Infective Agents