Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial
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| ClinicalTrials.gov Identifier: NCT00395226 |
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Recruitment Status :
Terminated
(Difficulty recruiting subjects)
First Posted : November 2, 2006
Results First Posted : June 30, 2011
Last Update Posted : June 30, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rosacea | Drug: zinc sulfate Drug: placebo | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 65 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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. |
| Study Start Date : | July 2006 |
| Actual Primary Completion Date : | July 2008 |
| Actual Study Completion Date : | July 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Zinc sulfate
220 mg of zinc sulfate
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Drug: zinc sulfate
zinc sulfate 220 mg bis for 90 days |
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Placebo Comparator: Lactose
270 mg lactose
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Drug: placebo
placebo bid for 90 days |
- Severity of Facial Rosacea After 90 Days of Treatment [ Time Frame: 90 days ]Modified Rosacea Severity Scoring System evaluating four signs of rosacea, flushing (transient erythema or redness), erythema (redness), papules and pustules and telangiectasia (spider-veins) ranges from 0 (best, absent) to 12 (worst, severe on all items)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Diagnosis of facial rosacea made or confirmed by one of the investigators.
- Severity of signs of rosacea "greater than mild" at the time of enrollment.
Exclusion Criteria:
- Treatment for rosacea during the 3 months prior to enrollment.
- Use of zinc dietary supplement > 25 mg per day during the 3 months prior to enrollment ( Most patients taking multivitamins with Zinc, often 15 mg per day, will not be excluded, whereas most patients taking additional Zinc supplements, often 25-50 mg per day or more will be excluded.)
- Diagnosis of rosacea fulminancy.
- Pregnant or breast feeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395226
| United States, Minnesota | |
| St. Mary's Duluth Clinic Health System | |
| Duluth, Minnesota, United States, 55805 | |
| Principal Investigator: | Joel Bamford, MD | Essentia Health |
| Responsible Party: | Joel Bamford, MD, St. Mary's duluth Clinic Health System |
| ClinicalTrials.gov Identifier: | NCT00395226 |
| Other Study ID Numbers: |
09-05-03 |
| First Posted: | November 2, 2006 Key Record Dates |
| Results First Posted: | June 30, 2011 |
| Last Update Posted: | June 30, 2011 |
| Last Verified: | June 2011 |
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Rosacea |
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Rosacea Skin Diseases Zinc Sulfate |
Astringents Physiological Effects of Drugs Dermatologic Agents |