A novel aqueous metronidazole 1% gel with hydrosolubilizing agents (HSA-3™)

Cutis

Volumn 77, Issue 4 SUPPL., 2006, Pages 18-26

  Dow, Gordon ^a   Basu, Sarmistha ^a  

^a Dow Pharmaceutical Sciences Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DERMATOLOGICAL AGENT; METRONIDAZOLE; PHARMACEUTICAL VEHICLES AND ADDITIVES;

ADOLESCENT; ADULT; AGED; CHEMISTRY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; FEMALE; FUNCTIONS OF THE SKIN AND ITS APPENDAGES; GEL; HOSPITALIZATION; HUMAN; INTRADERMAL DRUG ADMINISTRATION; MALE; MIDDLE AGED; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL; REVIEW; ROSACEA; TREATMENT OUTCOME;

ADMINISTRATION, CUTANEOUS; ADOLESCENT; ADULT; AGED; CHEMISTRY, PHARMACEUTICAL; DERMATOLOGIC AGENTS; FEMALE; GELS; HUMANS; MALE; METRONIDAZOLE; MIDDLE AGED; PHARMACEUTIC AIDS; ROSACEA; SEVERITY OF ILLNESS INDEX; SKIN PHYSIOLOGY; TREATMENT OUTCOME;

EID: 33646568811     PISSN: 00114162     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (29)

1. Nybaek H, Jemec GB. Photodynamic therapy in the treatment of rosacea. Dermatology. 2005;211:135-138.
2. Lehmann P. Rosacea. clinical features, pathogenesis and therapy [in German]. Hautarzt. 2005;56:871-885.
3. Gupta AK, Chaudhry M. Topical metronidazole for rosacea. Skin Therapy Lett. 2002;7:1-3, 6.
4. Aronson IK, Rumsfield JA, West DP, et al. Evaluation of topical metronidazole gel in acne rosacea. Drug Intell Clin Pharm. 1987;21:346-351.
5. Bleicher PA, Charles JH, Sober AJ. Topical metronidazole therapy for rosacea. Arch Dermatol. 1987;123:609-614.
6. Espagne E, Guillaume JC, Archimbaud A, et al. Double-blind study versus excipient of 0.75% metronidazole gel in the treatment of rosacea. Ann Dermatol Venereol. 1993;120:129-133.
7. Breneman D, Bucko A, Friedman D, et al. Evaluation of topical metronidazole lotion in rosacea. Poster presented at: 56th Annual Meeting of the American Academy of Dermatology; February 27-March 4, 1998; Orlando, Fla. P289.
8. Drake L, Leyden J, Lucky A, et al. Evaluation of topical metronidazole cream in rosacea. Poster presented at: 55th Annual Meeting of the American Academy of Dermatology; March 21-26, 1997; San Francisco, Calif. P65.
9. Bitar A, Bourgouin J, Doré N, et al. A double-blind randomised study of metronidazole (Flagyl) 1% cream in the treatment of acne rosacea. a placebo-controlled study. Drug Invest. 1990;2:242-248.
10. Bjerke JR, Nyfors A, Austad J, et al. Metronidazole (Elyzol) 1% cream v. placebo cream in the treatment of rosacea. Clin Trials J. 1989;26:187-194.
11. Breneman DL, Stewart D, Hevia O, et al. A double-blind, multicenter clinical trial comparing efficacy of once-daily metronidazole 1 percent cream to vehicle in patients with rosacea. Cutis. 1998;61:44-47.
12. Jorizzo JL, Lebwohl M, Tobey RE. The efficacy of metronidazole 1% cream once daily compared with metronidazole 1% cream twice daily and their vehicles in rosacea: a double-blind clinical trial. J Am Acad Dermatol. 1998;39:502-504.
13. Nielsen PG. A double-blind study of 1% metronidazole cream versus systemic oxytetracycline therapy for rosacea. Br J Dermatol. 1983;109:63-65.
14. Data on file. Beutner K. A single center, evaluator-blind evaluation of the cumulative irritation potential of metronidazole gel 1%, vehicle gel and control following repeated topical application to healthy subjects. Study Report 0215-R3.C-05-02. Fort Worth, Tex: Galderma Laboratories, LP; 2002.
15. Draelos ZD. Assessment of skin barrier function in rosacea patients with a novel 1% metronidazole gel. J Drugs Dermatol. 2005;4:557-562.
16. Data on file. Verrier C. Comparison of the in vitro liberation- penetration of metronidazole formulated in three different formulations through human skin. Study Report RDS.03.SRE.4720. Fort Worth, Tex: Galderma Laboratories, LP; 2002.
17. Data on file. Beutner K. Absorption of metronidazole following maximum topical exposure to metronidazole gel 1% in subjects with moderate to severe rosacea. Study Report 215-R3.C-04-02. Fort Worth, Tex: Galderma Laboratories, LP; 2004.
18. Data on file. Calman S. A phase I, single-center, biophysical assessment of the moisturization properties of metronidazole gel vehicle on the skin of healthy subjects aged 18-65 with moderate to dry skin. Study Report 0215-R3.C-01-05. Fort Worth, Tex: Galderma Laboratories, LP; 2005.
19. Metropolitan Life Insurance Company Height and Weight Charts. New York, NY: Metropolitan Life Insurance Company; 1959.
20. Amon I, Amon K, Huller H. Pharmacokinetics and therapeutic efficacy of metronidazole at different dosages. Int J Clin Pharmacol Biopharm. 1978;16:384-386.
21. Lamp KC, Freeman CD, Klutman NE, et al. Pharmacokinetics and pharmacodynamics of the nitroimidazole antimicrobials. Clin Pharmacokinet. 1999;36:353-373.
22. Crawford GH, Pelle MT, James WD. Rosacea: I: etiology, pathogenesis, and subtype classification. J Am Acad Dermatol. 2004:;51:327-341.
23. Gupta AK, Chaudhry MM. Rosacea and its management: an overview. J Eur Acad Dermatol Venereol. 2005;19: 273-285.
24. Draelos ZD. Facial hygiene and comprehensive management of rosacea. Cutis. 2004;73:183-187.
25. Del Rosso JQ. Medical treatment of rosacea with emphasis on topical therapies. Expert Opin Pharmacother. 2004;5:5-13.
26. Dahl MV, Jarratt M, Kaplan D, et al. Once-daily topical metronidazole cream formulations in the treatment of the papules and pustules of rosacea. J Am Acad Dermatol. 2001;45:723-730.
27. Aronson IK, Rumsfield JA, West DP, et al. Evaluation of topical metronidazole gel in acne rosacea. Drug Intell Clin Pharm. 1987;21:346-351.
28. Bleicher PA, Charles JH, Sober AJ. Topical metronidazole therapy for rosacea. Arch Dermatol. 1987;123:609-614.
29. Espagne E, Guillaume JC, Archimbaud A, et al. Double-blind study versus excipient of 0.75% metronidazole gel in the treatment of rosacea. Ann Dermatol Venereol. 1993;120:129-133.