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Warts

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Skin Diseases, Infectious

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Zinc

Two (2) corn starch pills will be taken three (3) times a day for 60 days.

Two (2) zinc gluconate 50 mg capsules will be taken three (3) times a day for 60 days.

Zinc gluconate

Corn starch pill

Rochelle L. Castillo, M.D.

Up to one-third of common warts can remain recalcitrant, an occurrence that has been attributed to impaired cell-mediated immunity. At present, no guidelines exist for the management of recalcitrant cutaneous warts. Zinc, a well-established immunomodulatory agent, has shown promise in this regard. Previous studies documenting the efficacy of oral zinc used zinc sulfate given at a maximum dose of 600 mg/day, equivalent to 140 mg of elemental zinc, which is over three times the recommended upper limit of 40 mg of elemental zinc per day. This raises concerns over safety and tolerability. In the Philippines, oral zinc is more widely available in chelated forms such as zinc gluconate, which have the benefit of improved absorption compared to non-chelated compounds such as zinc sulfate. This study will seek to determine if zinc gluconate 300 mg/day, equivalent to 40 mg of elemental zinc, will be efficacious in treating recalcitrant cutaneous warts. This lowered dose may have the added benefits of increased safety, tolerability, and cost-effectiveness.

Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial

Types and severity of adverse events will be noted on Day 30 (+5 days) and Day 60 (+5 days) by the primary investigator by verbally asking the subjects and by physically examining them

Types and severity of adverse events will be noted on Day 30 (+5 days) and Day 60 (+5 days) by the primary investigator by verbally asking the subjects and by physically examining them. Severity will be based on the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events by the National Institute Of Allergy And Infectious Diseases. For abnormalities not found in the DAIDS Toxicity Tables, the following scale will be used to estimate grade:

* Grade 1, Mild: No limitation in activity; no medical intervention/therapy required
* Grade 2, Moderate: Mild to moderate limitation in activity; no or minimal medical intervention required
* Grade 3, Severe: Marked limitation in activity; medical intervention required; hospitalization possible
* Grade 4, Life-Threatening: Extreme limitation in activity; significant medical intervention required; hospitalization or hospice care probable

The recurrence rate in patients who achieve complete response to zinc will be assessed at Day 120 or two months after discontinuation of zinc intake.

Philippine Dermatological Society

M.D.

Neoplasms

Digestive System Diseases

Adenocarcinoma

Barrett Esophagus

Metaplasia

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

zinc gluconate

James M Mullin, Ph.D.

Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:

1. can this zinc administration cause molecular-level changes in the Barrett's tissue?
2. are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?

14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.

Effect of Zinc on Barrett's Metaplasia

Sharpe-Strumia Research Foundation

Main Line Health

Professor

Mouth and Tooth Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

Pharmaceutical Solutions

The investigational product be administered for 63 days. Patient will use a spray based on zinc gluconate (three times a day)

The investigational product be administered for 63 days. Patient will use a solution based on sodium chloride and bicarbonate (5 times a day)

Zinc Gluconate

Sodium Bicarbonate

Carlo Lajolo, Prof.

Oral Mucositis (OM) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after RT exposure.

Gel X spray is a product based on zinc gluconate. It could be helpful to achieve the prevention of Oral Mucositis and, in case of OM manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations.

The aim of this study is to demonstrate the efficacy of the treatment with Gel X to reduce the incidence of oral mucositis, in comparison with Sodium Bicarbonate.

The study will be conducted as a single-blind randomized clinical trial (RCT). The population will be divided into two groups, receiving respectively the medical device and a solution based on Sodium Bicarbonate (5 g/L)

The principal investigator will be encharged of generating the allocation sequence, of enrolling the participants and of assigning the interventions to the participants.

The coworkers who will evaluate the onset of OM and its severity will be blinded about the selected product.

Prevention of Oral Mucositis in Head and Neck Cancer.

Prevention of Oral Mucositis in Subjects Undergoing Radiotherapy for Head and Neck Cancer. A Randomized Clinical Trial.

Catholic University of the Sacred Heart

Prof.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Zinc Gluconate as Treatment for Recalcitrant Cutaneous Warts: A Randomized, Double-blind, Placebo-controlled Trial	NCT01783353	Recalcitrant Cu...	Zinc gluconate Corn starch pil...	19 Years -	Philippine Dermatological Society
Effect of Zinc on Barrett's Metaplasia	NCT01984580	Barrett's Metap...	zinc gluconate	18 Years - 80 Years	Main Line Health
Effect of Zinc on Barrett's Metaplasia	NCT01984580	Barrett's Metap...	zinc gluconate	18 Years - 80 Years	Main Line Health
Effect of Zinc on Barrett's Metaplasia	NCT01984580	Barrett's Metap...	zinc gluconate	18 Years - 80 Years	Main Line Health
Prevention of Oral Mucositis in Head and Neck Cancer.	NCT05853692	Oral Mucositis	Zinc Gluconate Sodium Bicarbon...	18 Years -	Catholic University of the Sacred Heart

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