Clinical trial NCT01176994: Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
Official title: Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Skin Abnormality
Keywords: Patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation.
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Patients with skin lesions that are not treated with histology

Exclusion Criteria:

* Seriously ill patients

Primary outcomes:
measure: Safety
timeFrame: One year
measure: Safety of formulations
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References: