Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00395226
• Other study ID #: 09-05-03
• Status: Terminated
• Phase: N/A
• First received: October 31, 2006
• Last updated: June 3, 2011
• Start date: July 2006
• Est. completion date: July 2008

Study information

• Verified date: June 2011
• Source: Essentia Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• zinc sulfate
zinc sulfate 220 mg bis for 90 days
• placebo
placebo bid for 90 days

Locations

Country	Name	City	State
United States	St. Mary's Duluth Clinic Health System	Duluth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Essentia Health

Country where clinical trial is conducted

United States, 

References & Publications (32)

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Schosinsky KH, Lehmann HP, Beeler MF. Measurement of ceruloplasmin from its oxidase activity in serum by use of o-dianisidine dihydrochloride. Clin Chem. 1974 Dec;20(12):1556-63. — View Citation

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Thiboutot DM. Acne and rosacea. New and emerging therapies. Dermatol Clin. 2000 Jan;18(1):63-71, viii. Review. — View Citation

Tuleya S. Research Highlights: Acne and Rosacea Treatments. Skin and Agining.2003;11(8):70-72.

Verma KC, Saini AS, Dhamija SK. Oral zinc sulphate therapy in acne vulgaris: a double-blind trial. Acta Derm Venereol. 1980;60(4):337-40. — View Citation

West EC, Prohaska JR. Cu,Zn-superoxide dismutase is lower and copper chaperone CCS is higher in erythrocytes of copper-deficient rats and mice. Exp Biol Med (Maywood). 2004 Sep;229(8):756-64. — View Citation

Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. — View Citation

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Facial Rosacea After 90 Days of Treatment	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)	90 days	No