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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
History of Changes
Results First Received: June 3, 2011  
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
Condition: Rosacea
Interventions: Drug: zinc sulfate
Drug: placebo

  Participant Flow
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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
  Description
Placebo (Lactose) No text entered.
Zinc Sulfate No text entered.

Participant Flow:   Overall Study
    Placebo (Lactose)     Zinc Sulfate  
STARTED     26     27  
COMPLETED     22     22  
NOT COMPLETED     4     5  
Adverse Event                 4                 3  
Withdrawal by Subject                 0                 1  
Lost to Follow-up                 0                 1  



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

Baseline Measures
    Placebo (Lactose)     Zinc Sulfate     Total  
Number of Participants  
[units: participants]
 		  26     27     53  
Age  
[units: years]
Mean ± Standard Deviation 		  47.3  ± 13.4     52.8  ± 10.5     50.1  ± 12.2  
Gender  
[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 ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Brian Johnson
Organization: Essentia Institute of Rural Health
phone: 218-786-8856
e-mail: bjohnson3@eirh.org


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