Skin Abnormality Clinical Trial
Official title:
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic