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

NCT ID: NCT01176994

Last Updated: 2010-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-05-31

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.

Conditions

Skin Abnormality

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Skin lesions

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

Group Type: EXPERIMENTAL

Formulations for in-vivo fixation

Intervention Type: DEVICE

Formulations are comprised of non-toxic ingredients used in dermatology.

Interventions

Formulations for in-vivo fixation

Formulations are comprised of non-toxic ingredients used in dermatology.

Intervention Type: DEVICE

Other Intervention Names

Formulation ingredients:

Eligibility Criteria

Inclusion Criteria

• Patients with skin lesions that are not treated with histology

Exclusion Criteria

• Seriously ill patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hillel Yaffe Medical Center

Locations

Hillel Yaffe Medical Center

Hadera, , Israel

Countries

Israel

Facility Contacts

Michael Kahana, MD

Role: primary

kahanam@hy.health.gov.il

972-4-630-4667

Role: backup

ezrar@bezeqint.net

Other Identifiers

HYMC-0016-09

Identifier Type: -

Identifier Source: org_study_id