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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01176994
Enrollment
200
Registered
2010-08-06
Start date
2010-12-31
Completion date
2012-05-31
Last updated
2010-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Abnormality

Keywords

Patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation.

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.

Interventions

DEVICEFormulations for in-vivo fixation

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

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with skin lesions that are not treated with histology

Exclusion criteria

* Seriously ill patients

Design outcomes

Primary

MeasureTime frameDescription
SafetyOne yearInfiltration of formulations into skin lesions.
Safety of formulationsOne yearInfiltration 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026