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

NCT00395226 | Terminated Results

• 1 other identifier: 09-05-03
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rosacea

Keywords

Rosacea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Zinc sulfate

EXPERIMENTAL

220 mg of zinc sulfate

Drug: zinc sulfate

Lactose

PLACEBO COMPARATOR

270 mg lactose

Drug: placebo

Interventions

zinc sulfate DRUG

zinc sulfate 220 mg bis for 90 days

Zinc sulfate

placebo DRUG

placebo bid for 90 days

Lactose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Essentia Health: lead

Study Sites (1)

St. Mary's Duluth Clinic Health System

Duluth, Minnesota, 55805, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Rosacea

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Results Point of Contact

• Title: Brian Johnson
• Organization: Essentia Institute of Rural Health

bjohnson3@eirh.org

218-786-8856

Study Officials

• Joel Bamford, MD

  Essentia Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 2, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 30, 2011
• Results First Posted: June 30, 2011

Record last verified: 2011-06

Locations

US (1)