The development and optimization of a fixed combination of clindamycin and benzoyl peroxide aqueous gel

Journal of Drugs in Dermatology

Volumn 8, Issue 7, 2009, Pages 634-638

  Bucks, Daniel ^a   Sarpotdar, Pramod ^a   Yu, Karen ^a   Angel, Arturo ^a   Del Rosso, James ^b  

^a Dow Pharmaceutical Sciences Inc   (United States)

^b Mohave Skin and Cancer Clinics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BENZOYL PEROXIDE; CLINDAMYCIN; ORGANIC SOLVENT; PRESERVATIVE; SURFACTANT; ANTIINFECTIVE AGENT; DERMATOLOGICAL AGENT;

ACNE VULGARIS; ARTICLE; CONCENTRATION (PARAMETERS); DRUG DESIGN; DRUG EFFICACY; DRUG FORMULATION; DRY SKIN; HUMAN; HUMAN CELL; IN VITRO STUDY; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PROCESS OPTIMIZATION; SKIN IRRITATION; SYMPTOM; CLINICAL TRIAL; DOSE RESPONSE; GEL; PERMEABILITY; SINGLE BLIND PROCEDURE; SKIN ABSORPTION; TOXICITY TESTING;

ACNE VULGARIS; ANTI-BACTERIAL AGENTS; BENZOYL PEROXIDE; CLINDAMYCIN; DERMATOLOGIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; GELS; HUMANS; PERMEABILITY; SINGLE-BLIND METHOD; SKIN ABSORPTION; SKIN IRRITANCY TESTS;

EID: 67651174819     PISSN: 15459616     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (24)

1. Webster GF. Acne vulgaris. BMJ. 2002;325(7362):475-479.
2. Cunliffe WJ, Holland KT, Bojar R, Levy SF. A randomized, double-blind comparison of a clindamycin phosphate/benzoyl peroxide gel formulation and a matching clindamycin gel with respect to microbiologic activity and clinical efficacy in the topical treatment of acne vulgaris. Clin Ther. 2002; 24(7):1117-1133. (Pubitemid 34833234)
3. Leyden JJ, Kaidby K. Levy SF. The combination formulation of clindamycin 1% plus benzoyl peroxide 5% versus 3 different formulations of topical clindamycin alone in the reduction of Propionibacterium acnes. Am J Clin Derm. 2001;2(4): 263-266.
4. Lookingbill DP, Chalker DK, Lindholm JS, et al. Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide and vehicle gel: Combined results of two double-blind investigations. J Am Acad Dermatol. 1997:37(4):590-595. (Pubitemid 27446730)
5. Worret WI, Fluhr JW. Acne therapy with topical benzoyl peroxide, antibiotics and azelaic acid. J Dtsch Dermatol Ges. 2006;4(4):293-300. (Pubitemid 44139129)
6. Leyden JJ. Antibiotic resistance in the topical treatment of acne vulgaris. Cutis. 2004;73(Suppl 6):6-10. (Pubitemid 38843991)
7. Taylor GA, Shalita AR. Benzoyl peroxide-based combination therapies for acne vulgaris: A comparative review. Am J Clin Dermatol. 2004;5(4):261-265. (Pubitemid 39127968)
8. Ozolins M, Eady EA, Avery AJ, et al. Comparison of five antimicrobial regimens for treatment of mild to moderate inflammatory facial acnes vulgaris in the community: Randomised controlled trial. Lancet. 2004;364(9452):2188-2195. (Pubitemid 40018448)
9. Dosik J, Varnvakias G. Comparative irritation potential of two combination acne products. Am J Clin Dermatol. 2008;9(5):313-33.
10. Mills Jr. OH, Kligman AM, Pochi P, et al. Comparing 2.5%, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris. Int J Dermatol. 1986;25(10):664-667. (Pubitemid 17210594)
11. Kligman AM, Leyden JJ, Stewart R. New uses for benzoyl peroxide: A broad-spectrum antimicrobial agent. Int J Dermatol. 1977;16(5):413-417. (Pubitemid 8142815)
12. Bárány E, Lindberg M, Lodén M. Biophysical characterization of skin damage and recovery after exposure to different surfactants. Contact Dermatitis. 1999;40(2):98-103 (Pubitemid 29054396)
13. Effendy I, Maibach HI. Surfactants and experimental irritant contact dermatitis. Contact Dermatitis.1995; 33(4) 217-225.
14. Cserháti T. Alkyl ethoxylated and alkylphenol ethoxylated nonionic surfactants: Interaction with bioactive compounds and biological effects. Environ Health Perspect. 1995;103(4):358-364.
15. Soni MG, Taylor NA, Greenberg NA, et al. Evaluation of the health aspects of methyl paraben: A review of the published literature. Food Chem Toxicol. 2002;40(10):1335-1337.
16. Jorrizo J, Fluhr JW, Yu K, Chen D. Effect of clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) on transepidermal water loss and stratum corneum hydration: A comparative, randomized, controlled, observer-blind study to assess the effects of a fixed combination aqueous gel formulation. Abstract submitted to AAD Summer Academy Meeting, July 29-August 2, 2009, Boston, MA.
17. Del Rosso J. Pharmacotherapy Update: A closer look at topical metronidazole 1% gel. Skin & Aging. 2005;13(10):58-64.
18. Lanman BM, Elvers WB, Howard CS. The role of human patch testing in the product development program. Proceed Joint Conf Cosmet Sci Toilet Goods Assoc. 1968;135-145.
19. Nacht S, Yeung D, Beasley JN Jr, et al. Benzoyl peroxide: percutaneous penetration and metabolic disposition. J Am Acad Dermatol. 1981;4(1):31-37. (Pubitemid 11137313)
20. Morsches B, Holzmann H. Studies on the percutaneous absorption of benzoyl peroxide. Arzneimittelforschung. 1982;32(3):298-300.
21. Yeung D, Nacht S, Bucks D, Maibach HI. Benzoyl peroxide: Percutaneous penetration and metabolic disposition. II. Effect of concentration. J Am Acad Dermatol. 1983;9(6):920-924.
22. Seubert S, Seubert A, Ippen H. Penetration of benzoyl peroxide in the skin. Hautzart. 1984;35(9):455-458.
23. Thiboutot D, Zaenglein A, Weiss J, et al. An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: Assessment of efficacy and safety in 2813 patients. J Am Acad Dermatol 2008;59(5):792-800.
24. Lucky AW, Dinehart S, Fowler J, et al. Once daily and twice daily application s of a fixed combination clindamycin phosphate (1.2%) and low concentration benzoyl peroxide (2.5%) aqueous gel are effective and well-tolerated in moderate to severe acne. Poster presented at Winter Clincal Dermatology, January 17-20, 2009; Kohola Coast, Hawaii.