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

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ClinicalTrials.gov 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
Sponsor:
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
Enrollment 65
Recruitment Details 65 participants were recruited between August 2006 and April 2008
Pre-assignment Details 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).
Arm/Group Title Placebo (Lactose) Zinc Sulfate
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 26 27
Completed 22 22
Not Completed 4 5
Reason Not Completed
Adverse Event             4             3
Withdrawal by Subject             0             1
Lost to Follow-up             0             1
Arm/Group Title Placebo (Lactose) Zinc Sulfate Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 26 27 53
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 27 participants 53 participants
47.3  (13.4) 52.8  (10.5) 50.1  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 53 participants
Female
19
  73.1%
20
  74.1%
39
  73.6%
Male
7
  26.9%
7
  25.9%
14
  26.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 26 participants 27 participants 53 participants
Caucasian 24 26 50
Non-Caucasian 2 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 27 participants 53 participants
26 27 53
Length of Rosacea  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 26 participants 27 participants 53 participants
< 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] 
Mean (Standard Deviation)
Unit of measure:  Units on scale 0 to 12
Number Analyzed 26 participants 27 participants 53 participants
6.8  (1.4) 6.3  (1.2) 6.5  (1.3)
[1]
Measure Description: 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)
1.Primary Outcome
Title Severity of Facial Rosacea After 90 Days of Treatment
Hide Description 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)
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (Lactose) Zinc Sulfate
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 22 22
Mean (95% Confidence Interval)
Unit of Measure: units on scale 0 to 12
4.9
(4.1 to 5.6)
5.1
(4.2 to 6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Lactose), Zinc Sulfate
Comments The null hypothesis was “no group differences.” The alternative hypothesis was that the zinc sulfate arm is superior to placebo arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2840
Comments The a priori significance threshold level was 0.05 (two-sided)
Method ANCOVA
Comments The ANCOVA used group as a factor and baseline rosacea severity score as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
-0.47 to 1.62
Estimation Comments The effect of zinc sulfate treatment on rosacea severity score was estimated with baseline rosacea severity score included in the regression model
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Lactose) Zinc Sulfate
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Placebo (Lactose) Zinc Sulfate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Lactose) Zinc Sulfate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0      2    
Respiratory, thoracic and mediastinal disorders     
Pneumonia  0/25 (0.00%)  0 1/27 (3.70%)  1
Skin and subcutaneous tissue disorders     
Allergic reaction  0/25 (0.00%)  0 1/27 (3.70%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Lactose) Zinc Sulfate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/25 (60.00%)      15/27 (55.56%)    
Gastrointestinal disorders     
gastrointestinal disorders [1]  12/25 (48.00%)  15/27 (55.56%) 
Skin and subcutaneous tissue disorders     
rosacea outbreak [2]  3/25 (12.00%)  0/27 (0.00%) 
[1]
stomach upset, including nausea, discomfort, gas, diarrhea, constipation, and increased bowel movements
[2]
including redness and itching
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian Johnson
Organization: Essentia Institute of Rural Health
Phone: 218-786-8856
EMail: 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.
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.
Layout table for additonal information
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
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