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
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Essentia Health:

Primary Outcome Measures:
  • 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)


Enrollment: 65
Study Start Date: July 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc sulfate
220 mg of zinc sulfate
Drug: zinc sulfate
zinc sulfate 220 mg bis for 90 days
Placebo Comparator: Lactose
270 mg lactose
Drug: placebo
placebo bid for 90 days

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395226

Locations
United States, Minnesota
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
Sponsors and Collaborators
Essentia Health
Investigators
Principal Investigator: Joel Bamford, MD Essentia Health
  More Information

Publications:
Bikowski JB.Del Rosso JQ, Goldberg DJ, Margolis DJ, Van Zuuren EJ, Wolf JE. Future Trends in the Treatment of Rosacea. Cutis. 2005;75(Suppl 3):33-36
Tuleya S. Research Highlights: Acne and Rosacea Treatments. Skin and Agining.2003;11(8):70-72.
Hambridge M. Human Zinc Deficiency. J Nutrition. 2000;130:1344S-1349S.
Barceloux DG. Zinc. Clinical Toxicol. 1999;37(2):279-292.

Responsible Party: Joel Bamford, MD, St. Mary's duluth Clinic Health System
ClinicalTrials.gov Identifier: NCT00395226     History of Changes
Other Study ID Numbers: 09-05-03
Study First Received: October 31, 2006
Results First Received: June 3, 2011
Last Updated: June 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Essentia Health:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014