Rosacea
Conditions
Keywords
Rosacea
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.
Detailed description
Rosacea is a common chronic dermatological condition. The epidemiology of rosacea has not been determined extensively, due to part in problems with case definition. Rosacea is usually described as being most common in fair skinned women over the age of 40. However it occurs in most adult populations, including both men and women of all ages, and in people of many complexion types, including African Americans and Asians. Although rosacea is encountered frequently in primary care and dermatology practices, its precise incidence and prevalence are not known. The etiology and pathogenesis of rosacea are unknown. Both genetic and environmental factors are thought to be important. A wide range of medical and surgical interventions have been used in the management of rosacea, including dietary management, topical and systemic antibiotics, azelaic acid, low dose isotretinoin, and laser treatments for telangiectasia and rhinophyma. No single regimen has been found to be entirely satisfactory. Zinc has been found to be effective in managing several dermatological conditions, especially acne. It has also been found to be of benefit in dermatological conditions such as viral warts and cutaneous leishmaniasis. No studies have been published on the use of Zinc in the treatment of rosacea. This will be a prospective, double blind, randomized, controlled trial, comparing the effects of supplemental and placebo on the severity of rosacea. Enrolled subjects will be assigned to one of two study arms. Subjects and investigators will be blinded regarding treatment. After evaluation, meeting the study criteria,obtaining informed consent, and initiating study related procedures, the subject will take oral study drug or placebo, bid, for 90 days. Subjects are followed via phone call at one week and 6 weeks after enrollment into the study. At the conclusion of the 90 day study, subjects will be re-examined. The primary endpoint of this study will be the severity of rosacea at the end of the 90 day intervention period. The efficacy of Zinc vs. placebo will be assessed by a comparison of the change in the severity of rosacea.
Interventions
DRUGzinc sulfate
zinc sulfate 220 mg bis for 90 days
DRUGplacebo
placebo bid for 90 days
Sponsors
Essentia Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Facial Rosacea After 90 Days of Treatment | 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) |
Countries
United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Lactose) | 26 |
| Zinc Sulfate | 27 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo (Lactose) | Zinc Sulfate | Total |
|---|---|---|---|
| Age Continuous | 47.3 years STANDARD_DEVIATION 13.4 | 52.8 years STANDARD_DEVIATION 10.5 | 50.1 years STANDARD_DEVIATION 12.2 |
| Length of Rosacea > 10 years | 9 participant | 8 participant | 17 participant |
| Length of Rosacea 1-2 years | 0 participant | 3 participant | 3 participant |
| Length of Rosacea < 1 year | 1 participant | 2 participant | 3 participant |
| Length of Rosacea 2-5 years | 12 participant | 4 participant | 16 participant |
| Length of Rosacea 5-10 years | 4 participant | 10 participant | 14 participant |
| Race/Ethnicity, Customized Caucasian | 24 participant | 26 participant | 50 participant |
| Race/Ethnicity, Customized Non-Caucasian | 2 participant | 1 participant | 3 participant |
| Region of Enrollment United States | 26 participants | 27 participants | 53 participants |
| Rosacea Severity Score | 6.8 units on scale 0 to 12 STANDARD_DEVIATION 1.4 | 6.3 units on scale 0 to 12 STANDARD_DEVIATION 1.2 | 6.5 units on scale 0 to 12 STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 25 | 15 / 27 |
| serious Total, serious adverse events | 0 / — | 2 / — |
Outcome results
Primary
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)
Time frame: 90 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo (Lactose) | Severity of Facial Rosacea After 90 Days of Treatment | 4.9 units on scale 0 to 12 |
| Zinc Sulfate | Severity of Facial Rosacea After 90 Days of Treatment | 5.1 units on scale 0 to 12 |
Comparison: The null hypothesis was no group differences. The alternative hypothesis was that the zinc sulfate arm is superior to placebo arm.p-value: 0.28495% CI: [-0.47, 1.62]ANCOVA