Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395226
Status:
TERMINATED
Last Update Posted:
2011-06-30
First Post:
2006-10-31
Brief Title:
Zinc Sulfate in the Treatment of Rosacea A Randomized Controlled Trial
Sponsor:
Essentia Health
Organization:
Essentia Health
Study Overview
Official Title:
Zinc Sulfate in the Treatment of Rosacea A Randomized Controlled Trial Prospective Double Blind Randomized Controlled Trial Comparing the Effects of Supplemental Zinc Sulfate and Placebo on the Severity of Rosacea
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rosacea is a common chronic dermatological condition characterized by recurrent or persistent redness permanent dilation of small blood vessel causing small red lesions and papulespustules The signs of rosacea are usually confined to the face but may appear on the neck scalp or trunk Opthalmologic findings are also common Rosacea is usually described as being most common in fair skinned women over 40 The purpose of the study is to determine whether oral Zinc Sulfate treatment is an effective treatment for facial rosacea
Detailed Description:
Rosacea is a common chronic dermatological condition The epidemiology of rosacea has not been determined extensively due to part in problems with case definition Rosacea is usually described as being most common in fair skinned women over the age of 40 However it occurs in most adult populations including both men and women of all ages and in people of many complexion types including African Americans and Asians
Although rosacea is encountered frequently in primary care and dermatology practices its precise incidence and prevalence are not known The etiology and pathogenesis of rosacea are unknown Both genetic and environmental factors are thought to be important A wide range of medical and surgical interventions have been used in the management of rosacea including dietary management topical and systemic antibiotics azelaic acid low dose isotretinoin and laser treatments for telangiectasia and rhinophyma No single regimen has been found to be entirely satisfactory
Zinc has been found to be effective in managing several dermatological conditions especially acne It has also been found to be of benefit in dermatological conditions such as viral warts and cutaneous leishmaniasis
No studies have been published on the use of Zinc in the treatment of rosacea This will be a prospective double blind randomized controlled trial comparing the effects of supplemental and placebo on the severity of rosacea Enrolled subjects will be assigned to one of two study arms
Subjects and investigators will be blinded regarding treatment After evaluation meeting the study criteriaobtaining informed consent and initiating study related procedures the subject will take oral study drug or placebo bid for 90 days
Subjects are followed via phone call at one week and 6 weeks after enrollment into the study At the conclusion of the 90 day study subjects will be re-examined
The primary endpoint of this study will be the severity of rosacea at the end of the 90 day intervention period
The efficacy of Zinc vs placebo will be assessed by a comparison of the change in the severity of rosacea
Although rosacea is encountered frequently in primary care and dermatology practices its precise incidence and prevalence are not known The etiology and pathogenesis of rosacea are unknown Both genetic and environmental factors are thought to be important A wide range of medical and surgical interventions have been used in the management of rosacea including dietary management topical and systemic antibiotics azelaic acid low dose isotretinoin and laser treatments for telangiectasia and rhinophyma No single regimen has been found to be entirely satisfactory
Zinc has been found to be effective in managing several dermatological conditions especially acne It has also been found to be of benefit in dermatological conditions such as viral warts and cutaneous leishmaniasis
No studies have been published on the use of Zinc in the treatment of rosacea This will be a prospective double blind randomized controlled trial comparing the effects of supplemental and placebo on the severity of rosacea Enrolled subjects will be assigned to one of two study arms
Subjects and investigators will be blinded regarding treatment After evaluation meeting the study criteriaobtaining informed consent and initiating study related procedures the subject will take oral study drug or placebo bid for 90 days
Subjects are followed via phone call at one week and 6 weeks after enrollment into the study At the conclusion of the 90 day study subjects will be re-examined
The primary endpoint of this study will be the severity of rosacea at the end of the 90 day intervention period
The efficacy of Zinc vs placebo will be assessed by a comparison of the change in the severity of rosacea
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None