Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Difficulty recruiting subjects)
Sponsor:
Information provided by:
Essentia Health
ClinicalTrials.gov Identifier:
NCT00395226
First received: October 31, 2006
Last updated: June 3, 2011
Last verified: June 2011

October 31, 2006
June 3, 2011
July 2006
July 2008   (final data collection date for primary outcome measure)
Severity of Facial Rosacea After 90 Days of Treatment [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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)
  • a comparison of the change in severity of rosacea determined by a
  • Severity of rosacea at the end of the 90 day intervention period as assessed by
  • standard grading system for rosacea.
Complete list of historical versions of study NCT00395226 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial
"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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rosacea
  • Drug: zinc sulfate
    zinc sulfate 220 mg bis for 90 days
  • Drug: placebo
    placebo bid for 90 days
  • Experimental: Zinc sulfate
    220 mg of zinc sulfate
    Intervention: Drug: zinc sulfate
  • Placebo Comparator: Lactose
    270 mg lactose
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
65
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00395226
09-05-03
No
Joel Bamford, MD, St. Mary's duluth Clinic Health System
Essentia Health
Not Provided
Principal Investigator: Joel Bamford, MD Essentia Health
Essentia Health
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP