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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395226
Recruitment Status : Terminated (Difficulty recruiting subjects)
First Posted : November 2, 2006
Results First Posted : June 30, 2011
Last Update Posted : June 30, 2011
Information provided by:
Essentia Health

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rosacea
Interventions: Drug: zinc sulfate
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
65 participants were recruited between August 2006 and April 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
65 participants were assessed for eligibility. 12 did not meet inclusion criteria (severity of facial rosacea “greater than mild” at the time of enrollment, at least 5 of 12 on the Modified Rosacea Severity Scoring System).

Reporting Groups
Placebo (Lactose) No text entered.
Zinc Sulfate No text entered.

Participant Flow:   Overall Study
    Placebo (Lactose)   Zinc Sulfate
STARTED   26   27 
COMPLETED   22   22 
Adverse Event                4                3 
Withdrawal by Subject                0                1 
Lost to Follow-up                0                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Placebo (Lactose) No text entered.
Zinc Sulfate No text entered.
Total Total of all reporting groups

Baseline Measures
   Placebo (Lactose)   Zinc Sulfate   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   27   53 
[Units: Years]
Mean (Standard Deviation)
 47.3  (13.4)   52.8  (10.5)   50.1  (12.2) 
[Units: Participants]
Female   19   20   39 
Male   7   7   14 
Race/Ethnicity, Customized 
[Units: Participant]
Caucasian   24   26   50 
Non-Caucasian   2   1   3 
Region of Enrollment 
[Units: Participants]
United States   26   27   53 
Length of Rosacea 
[Units: Participant]
< 1 year   1   2   3 
1-2 years   0   3   3 
2-5 years   12   4   16 
5-10 years   4   10   14 
> 10 years   9   8   17 
Rosacea Severity Score [1] 
[Units: Units on scale 0 to 12]
Mean (Standard Deviation)
 6.8  (1.4)   6.3  (1.2)   6.5  (1.3) 
[1] 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)

  Outcome Measures

1.  Primary:   Severity of Facial Rosacea After 90 Days of Treatment   [ Time Frame: 90 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Brian Johnson
Organization: Essentia Institute of Rural Health
phone: 218-786-8856

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.
Walker CF, Black RE. Zinc and the Risk for Infectious Disease. ann Intern Med. 1996;125(2):81-88.
___.What's New about Zinc. UC Berkeley Wellness Letter. 2004:130:1344S-1349S.
Hambridge M. Human Zinc Deficiency. J Nutrition. 2000;130:1344S-1349S.

Responsible Party: Joel Bamford, MD, St. Mary's duluth Clinic Health System Identifier: NCT00395226     History of Changes
Other Study ID Numbers: 09-05-03
First Submitted: October 31, 2006
First Posted: November 2, 2006
Results First Submitted: June 3, 2011
Results First Posted: June 30, 2011
Last Update Posted: June 30, 2011