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

Early Phase 1

• Conditions: Skin Abnormality
• Interventions: Device: Formulations for in-vivo fixation

• Registration Number: NCT01176994
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-05
• Last Update Submitted: 2010-08-05
• Study First Posted: 2010-08-06
• Last Update Posted: 2010-08-06
• Study Start: 2010-12
• Primary Completion: 2011-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with skin lesions that are not treated with histology

Exclusion Criteria

• Seriously ill patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin lesions	Formulations for in-vivo fixation	Individuals with skin lesions whose lesions are not sent for histology by dermatologists

Primary Outcome Measures

Name	Time	Method
Safety	One year	Infiltration of formulations into skin lesions.
Safety of formulations	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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel