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Trial Outcomes & Findings for Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial (NCT NCT00395226)

NCT ID: NCT00395226

Last Updated: 2011-06-30

Results Overview

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)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

90 days

Results posted on

2011-06-30

Participant Flow

65 participants were recruited between August 2006 and April 2008

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).

Participant milestones

Participant milestones
Measure
Placebo (Lactose)
Zinc Sulfate
Overall Study
STARTED
26
27
Overall Study
COMPLETED
22
22
Overall Study
NOT COMPLETED
4
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo (Lactose)
Zinc Sulfate
Overall Study
Adverse Event
4
3
Overall Study
Withdrawal by Subject
0
1
Overall Study
Lost to Follow-up
0
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo (Lactose)
n=26 Participants
Zinc Sulfate
n=27 Participants
Total
n=53 Participants
Total of all reporting groups
Age Continuous
47.3 years
STANDARD_DEVIATION 13.4 • n=5 Participants
52.8 years
STANDARD_DEVIATION 10.5 • n=7 Participants
50.1 years
STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male
Female
19 Participants
n=5 Participants
20 Participants
n=7 Participants
39 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
24 participant
n=5 Participants
26 participant
n=7 Participants
50 participant
n=5 Participants
Race/Ethnicity, Customized
Non-Caucasian
2 participant
n=5 Participants
1 participant
n=7 Participants
3 participant
n=5 Participants
Region of Enrollment
United States
26 participants
n=5 Participants
27 participants
n=7 Participants
53 participants
n=5 Participants
Length of Rosacea
< 1 year
1 participant
n=5 Participants
2 participant
n=7 Participants
3 participant
n=5 Participants
Length of Rosacea
1-2 years
0 participant
n=5 Participants
3 participant
n=7 Participants
3 participant
n=5 Participants
Length of Rosacea
2-5 years
12 participant
n=5 Participants
4 participant
n=7 Participants
16 participant
n=5 Participants
Length of Rosacea
5-10 years
4 participant
n=5 Participants
10 participant
n=7 Participants
14 participant
n=5 Participants
Length of Rosacea
> 10 years
9 participant
n=5 Participants
8 participant
n=7 Participants
17 participant
n=5 Participants
Rosacea Severity Score
6.8 units on scale 0 to 12
STANDARD_DEVIATION 1.4 • n=5 Participants
6.3 units on scale 0 to 12
STANDARD_DEVIATION 1.2 • n=7 Participants
6.5 units on scale 0 to 12
STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: 90 days

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

Outcome measures
Measure
Placebo (Lactose)
n=22 Participants
Zinc Sulfate
n=22 Participants
Severity of Facial Rosacea After 90 Days of Treatment
4.9 units on scale 0 to 12
Interval 4.1 to 5.6
5.1 units on scale 0 to 12
Interval 4.2 to 6.0

Adverse Events

Placebo (Lactose)

Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths

Zinc Sulfate

Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo (Lactose)
n=25 participants at risk
Zinc Sulfate
n=27 participants at risk
Skin and subcutaneous tissue disorders
Allergic reaction
0.00%
0/25
3.7%
1/27 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Pneumonia
0.00%
0/25
3.7%
1/27 • Number of events 1

Other adverse events

Other adverse events
Measure
Placebo (Lactose)
n=25 participants at risk
Zinc Sulfate
n=27 participants at risk
Gastrointestinal disorders
gastrointestinal disorders
48.0%
12/25
55.6%
15/27
Skin and subcutaneous tissue disorders
rosacea outbreak
12.0%
3/25
0.00%
0/27

Additional Information

Brian Johnson

Essentia Institute of Rural Health

Phone: 218-786-8856

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place