Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
NCT01176994 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2010-08-06
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.
Conditions
- Skin Abnormality
Interventions
- DEVICE
-
Formulations for in-vivo fixation
Formulations are comprised of non-toxic ingredients used in dermatology.
Sponsors & Collaborators
-
Hillel Yaffe Medical Center
lead OTHER_GOV
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2011-05-31
- Completion
- 2012-05-31
Countries
- Israel
Study Locations
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