Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Abnormality |
Device: Formulations for in-vivo fixation |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions. |
- Safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]Infiltration of formulations into skin lesions.
- Safety of formulations [ Time Frame: One year ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Skin lesions
Individuals with skin lesions whose lesions are not sent for histology by dermatologists
|
Device: Formulations for in-vivo fixation
Formulations are comprised of non-toxic ingredients used in dermatology.
Other Name: Formulation ingredients:
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients with skin lesions that are not treated with histology
Exclusion Criteria:
- Seriously ill patients
Contacts and Locations| Israel | |
| Hillel Yaffe Medical Center | Not yet recruiting |
| Hadera, Israel, 38100 | |
| Contact: Michael Kahana, MD 972-4-630-4667 kahanam@hy.health.gov.il | |
| Contact ezrar@bezeqint.net | |
| Principal Investigator: Michael Kahana, MD | |
| Sub-Investigator: Rafael Ezra, MSc Pharm | |
More Information
No publications provided
| Responsible Party: | Michael Kahana, MD, Hillel Yaffe Medical Center |
| ClinicalTrials.gov Identifier: | NCT01176994 History of Changes |
| Other Study ID Numbers: | HYMC-0016-09 |
| Study First Received: | August 5, 2010 |
| Last Updated: | August 5, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Hillel Yaffe Medical Center:
|
Patients with skin lesions that are treated by dermatologists with destructive modalities without histological evaluation. |
Additional relevant MeSH terms:
|
Congenital Abnormalities Skin Abnormalities Skin Diseases Formaldehyde |
Disinfectants Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013