|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
St. Mary's Duluth Clinic Health System |
|---|---|
| Information provided by: | St. Mary's Duluth Clinic Health System |
| ClinicalTrials.gov Identifier: | NCT00395226 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Rosacea |
Drug: zinc sulfate Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| 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. |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2: Placebo Comparator
placebo compared to zinc sulfate
|
Drug: zinc sulfate
zinc sulfate 220 mg bis for 90 days
Drug: placebo
placebo bid for 90 days
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| St. Mary's Duluth Clinic Health System | |
| Duluth, Minnesota, United States, 55805 | |
| Principal Investigator: | Joel Bamford, MD | St. Mary's Duluth Clinic Health System |
More Information
| Responsible Party: | St. Mary's duluth Clinic Health System ( Joel Bamford, MD ) |
| Study ID Numbers: | 09-05-03 |
| Study First Received: | October 31, 2006 |
| Last Updated: | January 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00395226 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Rosacea |
|
Rosacea Skin Diseases Zinc Sulfate |
Zinc Trace Elements Micronutrients |
|
Rosacea Skin Diseases Zinc Sulfate Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Zinc Astringents Trace Elements Micronutrients Dermatologic Agents Pharmacologic Actions |
