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Zinc Sulfate in the Treatment of Rosacea: A Randomized, Controlled Trial
This study has been terminated.
( Difficulty recruiting subjects )
Study NCT00395226   Information provided by Essentia Health

First Received on October 31, 2006.   Last Updated on June 3, 2011   History of Changes
Results First Received: June 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rosacea
Interventions: Drug: zinc sulfate
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
65 participants were recruited between August 2006 and April 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Placebo (Lactose) No text entered.
Zinc Sulfate No text entered.

Participant Flow:   Overall Study
    Placebo (Lactose)     Zinc Sulfate  
STARTED     26     27  
COMPLETED     22     22  
NOT COMPLETED     4     5  
Adverse Event                 4                 3  
Withdrawal by Subject                 0                 1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo (Lactose) No text entered.
Zinc Sulfate No text entered.

Baseline Measures
    Placebo (Lactose)     Zinc Sulfate     Total  
Number of Participants  
[units: participants]
 		  26     27     53  
Age  
[units: years]
Mean ± Standard Deviation 		  47.3  ± 13.4     52.8  ± 10.5     50.1  ± 12.2  
Gender  
[units: participants]
 		     
Female     19     20     39  
Male     7     7     14  
Race/Ethnicity, Customized  
[units: participant]
 		     
Caucasian     24     26     50  
Non-Caucasian     2     1     3  
Region of Enrollment  
[units: participants]
 		     
United States     26     27     53  
Length of Rosacea  
[units: participant]
 		     
< 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]
[units: units on scale 0 to 12]
Mean ± Standard Deviation 		  6.8  ± 1.4     6.3  ± 1.2     6.5  ± 1.3  
[1] 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

1.  Primary:   Severity of Facial Rosacea After 90 Days of Treatment   [ Time Frame: 90 days ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Brian Johnson
Organization: Essentia Institute of Rural Health
phone: 218-786-8856
e-mail: bjohnson3@eirh.org


Publications:
Berg M, Liden S. An epidemiological study of rosacea. Acta Derm Venereol. 1989;69(5):419-23.
Bamford JT. Rosacea: current thoughts on origin. Semin Cutan Med Surg. 2001 Sep;20(3):199-206. Review.
Millikan L. The proposed inflammatory pathophysiology of rosacea: implications for treatment. Skinmed. 2003 Jan-Feb;2(1):43-7. Review.
Wilkin JK. Rosacea. Pathophysiology and treatment. Arch Dermatol. 1994 Mar;130(3):359-62. Review. No abstract available.
Thiboutot DM. Acne and rosacea. New and emerging therapies. Dermatol Clin. 2000 Jan;18(1):63-71, viii. Review.
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.
Fraker PJ, King LE. Reprogramming of the immune system during zinc deficiency. Annu Rev Nutr. 2004;24:277-98. Review.
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. Review.
Fischer Walker C, Black RE. Zinc and the risk for infectious disease. Annu Rev Nutr. 2004;24:255-75. Review.
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.
Hambridge M. Human Zinc Deficiency. J Nutrition. 2000;130:1344S-1349S.
Hoffman HN 2nd, Phyliky RL, Fleming CR. Zinc-induced copper deficiency. Gastroenterology. 1988 Feb;94(2):508-12.
Salzman MB, Smith EM, Koo C. Excessive oral zinc supplementation. J Pediatr Hematol Oncol. 2002 Oct;24(7):582-4.
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.
Chandra RK. Excessive intake of zinc impairs immune responses. JAMA. 1984 Sep 21;252(11):1443-6.
Barceloux DG. Zinc. Clinical Toxicol. 1999;37(2):279-292.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. Review.
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.
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. No abstract available.


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
Study First Received: October 31, 2006
Results First Received: June 3, 2011
Last Updated: June 3, 2011
Health Authority: United States: Institutional Review Board





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