Clinical trial NCT00395226: Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rosacea
Keywords: Rosacea
Lead sponsor: Essentia Health
Sponsor class: OTHER
First posted: 2006-11-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity of Facial Rosacea After 90 Days of Treatment
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Health System
state: Minnesota
Study officials:
affiliation: Essentia Health
name: Joel Bamford, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berg M, Liden S. An epidemiological study of rosacea. Acta Derm Venereol. 1989;69(5):419-23.
citation: Bamford JT. Rosacea: current thoughts on origin. Semin Cutan Med Surg. 2001 Sep;20(3):199-206. doi: 10.1053/sder.2001.27553.
citation: Millikan 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.
citation: Wilkin JK. Rosacea. Pathophysiology and treatment. Arch Dermatol. 1994 Mar;130(3):359-62. doi: 10.1001/archderm.130.3.359. No abstract available.
citation: Thiboutot 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.
citation: 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
citation: Tuleya S. Research Highlights: Acne and Rosacea Treatments. Skin and Agining.2003;11(8):70-72.
citation: 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.
citation: Fraker 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.
citation: Walker CF, Black RE. Zinc and the Risk for Infectious Disease. ann Intern Med. 1996;125(2):81-88.
citation: 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.
citation: ___.What's New about Zinc. UC Berkeley Wellness Letter. 2004:130:1344S-1349S.
citation: Hambidge M. Human zinc deficiency. J Nutr. 2000 May;130(5S Suppl):1344S-9S. doi: 10.1093/jn/130.5.1344S.
citation: Hoffman 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.
citation: Salzman 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.
citation: Irving JA, Mattman A, Lockitch G, Farrell K, Wadsworth LD. Element of caution: a case of reversible cytopenias associated with excessive zinc supplementation. CMAJ. 2003 Jul 22;169(2):129-31.
citation: Chandra RK. Excessive intake of zinc impairs immune responses. JAMA. 1984 Sep 21;252(11):1443-6.
citation: Barceloux DG. Zinc. J Toxicol Clin Toxicol. 1999;37(2):279-92. doi: 10.1081/clt-100102426.
citation: Schosinsky KH, Lehmann HP, Beeler MF. Measurement of ceruloplasmin from its oxidase activity in serum by use of o-dianisidine dihydrochloride. Clin Chem. 1974 Dec;20(12):1556-63. No abstract available.
citation: West EC, Prohaska JR. Cu,Zn-superoxide dismutase is lower and copper chaperone CCS is higher in erythrocytes of copper-deficient rats and mice. Exp Biol Med (Maywood). 2004 Sep;229(8):756-64. doi: 10.1177/153537020422900807.
citation: Dreno B, Amblard P, Agache P, Sirot S, Litoux P. Low doses of zinc gluconate for inflammatory acne. Acta Derm Venereol. 1989;69(6):541-3.
citation: Dreno B, Moyse D, Alirezai M, Amblard P, Auffret N, Beylot C, Bodokh I, Chivot M, Daniel F, Humbert P, Meynadier J, Poli F; Acne Research and Study Group. Multicenter randomized comparative double-blind controlled clinical trial of the safety and efficacy of zinc gluconate versus minocycline hydrochloride in the treatment of inflammatory acne vulgaris. Dermatology. 2001;203(2):135-40. doi: 10.1159/000051728.
citation: Chu A, Huber FJ, Plott RT. The comparative efficacy of benzoyl peroxide 5%/erythromycin 3% gel and erythromycin 4%/zinc 1.2% solution in the treatment of acne vulgaris. Br J Dermatol. 1997 Feb;136(2):235-8.
citation: Meynadier J. Efficacy and safety study of two zinc gluconate regimens in the treatment of inflammatory acne. Eur J Dermatol. 2000 Jun;10(4):269-73.
citation: Schachner L, Eaglstein W, Kittles C, Mertz P. Topical erythromycin and zinc therapy for acne. J Am Acad Dermatol. 1990 Feb;22(2 Pt 1):253-60. doi: 10.1016/0190-9622(90)70034-f.
citation: Verma KC, Saini AS, Dhamija SK. Oral zinc sulphate therapy in acne vulgaris: a double-blind trial. Acta Derm Venereol. 1980;60(4):337-40. doi: 10.2340/0001555560337340.
citation: Al-Gurairi FT, Al-Waiz M, Sharquie KE. Oral zinc sulphate in the treatment of recalcitrant viral warts: randomized placebo-controlled clinical trial. Br J Dermatol. 2002 Mar;146(3):423-31. doi: 10.1046/j.1365-2133.2002.04617.x.
citation: Sharquie KE, Najim RA, Farjou IB, Al-Timimi DJ. Oral zinc sulphate in the treatment of acute cutaneous leishmaniasis. Clin Exp Dermatol. 2001 Jan;26(1):21-6. doi: 10.1046/j.1365-2230.2001.00752.x.
citation: Berne B, Venge P, Ohman S. Perifolliculitis capitis abscedens et suffodiens (Hoffman). Complete healing associated with oral zinc therapy. Arch Dermatol. 1985 Aug;121(8):1028-30.
citation: Rostan EF, DeBuys HV, Madey DL, Pinnell SR. Evidence supporting zinc as an important antioxidant for skin. Int J Dermatol. 2002 Sep;41(9):606-11. doi: 10.1046/j.1365-4362.2002.01567.x.
citation: Dreno B, Trossaert M, Boiteau HL, Litoux P. Zinc salts effects on granulocyte zinc concentration and chemotaxis in acne patients. Acta Derm Venereol. 1992 Aug;72(4):250-2.
citation: Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. doi: 10.1016/j.jaad.2004.01.048. No abstract available.