Rosacea Clinical Trial
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.
Rosacea is a common chronic dermatological condition, characterized by recurrent or persistent redness, permanent dilation of small blood vessel causing small red lesions, and papules/pustules. 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.
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 criteria,obtaining 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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