RosaceaNCT00395226
Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial
A study testing zinc sulfate in people with Rosacea, run by Essentia Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- zinc sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Mary's Duluth Clinic Health System
Duluth, Minnesota, 55805
About this study
Official title: "Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial." Prospective, Double Blind, Randomized, Controlled Trial Comparing the Effects of Supplemental Zinc Sulfate and Placebo on the Severity of Rosacea.
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.
Read the 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.
- Conditions
- Rosacea
- Being tested
- zinc sulfate, placebo
- Keywords
- Rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc sulfateDrug
zinc sulfate 220 mg bis for 90 days
placeboDrug
placebo bid for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Zinc sulfate | Experimental | 220 mg of zinc sulfate Receives: Drug: zinc sulfate |
| Lactose | Placebo comparator | 270 mg lactose Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Difficulty recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Investigators
- Joel Bamford, MD, Principal investigator, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395226
- Sponsor's protocol ID
- 09-05-03
- Status last verified
- Jun 2011
- First submitted
- 31 Oct 2006
- Last updated
- 30 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Berg M, Liden S. An epidemiological study of rosacea. Acta Derm Venereol. 1989;69(5):419-23.
PubMed 2572109Bamford JT. Rosacea: current thoughts on origin. Semin Cutan Med Surg. 2001 Sep;20(3):199-206. doi: 10.1053/sder.2001.27553.
PubMed 11594675Millikan L. The proposed inflammatory pathophysiology of rosacea: implications for treatment. Skinmed. 2003 Jan-Feb;2(1):43-7. doi: 10.1111/j.1540-9740.2003.01876.x.
PubMed 14673323Wilkin JK. Rosacea. Pathophysiology and treatment. Arch Dermatol. 1994 Mar;130(3):359-62. doi: 10.1001/archderm.130.3.359. No abstract available.
PubMed 8129416Thiboutot DM. Acne and rosacea. New and emerging therapies. Dermatol Clin. 2000 Jan;18(1):63-71, viii. doi: 10.1016/s0733-8635(05)70147-9.
PubMed 10626112Bikowski 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.
Fraker PJ, King LE. Reprogramming of the immune system during zinc deficiency. Annu Rev Nutr. 2004;24:277-98. doi: 10.1146/annurev.nutr.24.012003.132454.
PubMed 15189122Fraker PJ, King LE, Laakko T, Vollmer TL. The dynamic link between the integrity of the immune system and zinc status. J Nutr. 2000 May;130(5S Suppl):1399S-406S. doi: 10.1093/jn/130.5.1399S.
PubMed 10801951Walker CF, Black RE. Zinc and the Risk for Infectious Disease. ann Intern Med. 1996;125(2):81-88.
Mossad SB, Macknin ML, Medendorp SV, Mason P. Zinc gluconate lozenges for treating the common cold. A randomized, double-blind, placebo-controlled study. Ann Intern Med. 1996 Jul 15;125(2):81-8. doi: 10.7326/0003-4819-125-2-199607150-00001.
PubMed 8678384___.What's New about Zinc. UC Berkeley Wellness Letter. 2004:130:1344S-1349S.
Hambidge M. Human zinc deficiency. J Nutr. 2000 May;130(5S Suppl):1344S-9S. doi: 10.1093/jn/130.5.1344S.
PubMed 10801941Hoffman HN 2nd, Phyliky RL, Fleming CR. Zinc-induced copper deficiency. Gastroenterology. 1988 Feb;94(2):508-12. doi: 10.1016/0016-5085(88)90445-3.
PubMed 3335323Salzman MB, Smith EM, Koo C. Excessive oral zinc supplementation. J Pediatr Hematol Oncol. 2002 Oct;24(7):582-4. doi: 10.1097/00043426-200210000-00020.
PubMed 12368702
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial." Prospective, Double Blind, Randomized, Controlled Trial Comparing the Effects of Supplemental Zinc Sulfate and Placebo on the Severity of Rosacea.
- ClinicalTrials.gov ID
- NCT00395226
- Acronym / sponsor ID
- 09-05-03
- Conditions
- Rosacea
- Keywords
- Rosacea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting subjects
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Posted 30 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc sulfate | Experimental | Drug: zinc sulfate220 mg of zinc sulfate |
| Lactose | Placebo comparator | Drug: placebo270 mg lactose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc sulfatezinc sulfate 220 mg bis for 90 days | Drug | Zinc sulfate |
| placeboplacebo bid for 90 days | Drug | Lactose |
Primary outcome
Severity of Facial Rosacea After 90 Days of Treatment
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2572109Berg M, Liden S. An epidemiological study of rosacea. Acta Derm Venereol. 1989;69(5):419-23.
- Background: PubMed 11594675Bamford JT. Rosacea: current thoughts on origin. Semin Cutan Med Surg. 2001 Sep;20(3):199-206. doi: 10.1053/sder.2001.27553.
- Background: PubMed 14673323Millikan L. The proposed inflammatory pathophysiology of rosacea: implications for treatment. Skinmed. 2003 Jan-Feb;2(1):43-7. doi: 10.1111/j.1540-9740.2003.01876.x.
- Background: PubMed 8129416Wilkin JK. Rosacea. Pathophysiology and treatment. Arch Dermatol. 1994 Mar;130(3):359-62. doi: 10.1001/archderm.130.3.359. No abstract available.
- Background: PubMed 10626112Thiboutot DM. Acne and rosacea. New and emerging therapies. Dermatol Clin. 2000 Jan;18(1):63-71, viii. doi: 10.1016/s0733-8635(05)70147-9.
- BackgroundBikowski 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
- BackgroundTuleya S. Research Highlights: Acne and Rosacea Treatments. Skin and Agining.2003;11(8):70-72.
- Background: PubMed 15189122Fraker PJ, King LE. Reprogramming of the immune system during zinc deficiency. Annu Rev Nutr. 2004;24:277-98. doi: 10.1146/annurev.nutr.24.012003.132454.
- Background: PubMed 10801951Fraker PJ, King LE, Laakko T, Vollmer TL. The dynamic link between the integrity of the immune system and zinc status. J Nutr. 2000 May;130(5S Suppl):1399S-406S. doi: 10.1093/jn/130.5.1399S.
- BackgroundWalker CF, Black RE. Zinc and the Risk for Infectious Disease. ann Intern Med. 1996;125(2):81-88.
- Background: PubMed 8678384Mossad SB, Macknin ML, Medendorp SV, Mason P. Zinc gluconate lozenges for treating the common cold. A randomized, double-blind, placebo-controlled study. Ann Intern Med. 1996 Jul 15;125(2):81-8. doi: 10.7326/0003-4819-125-2-199607150-00001.
- Background___.What's New about Zinc. UC Berkeley Wellness Letter. 2004:130:1344S-1349S.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Bamford, MD principal investigator
Essentia Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zinc sulfate in people with Rosacea, run by Essentia Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Facial Rosacea After 90 Days of Treatment (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00395226, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2011.