Skip to main content
Top
Published in: American Journal of Clinical Dermatology 1/2001

01-02-2001 | Original Research Article

Comparison of the Efficacy and Safety of a Combination Topical Gel Formulation of Benzoyl Peroxide and Clindamycin with Benzoyl Peroxide, Clindamycin and Vehicle Gel in the Treatments of Acne Vulgaris

Authors: James J. Leyden, Richard S. Berger, Frank E. Dunlap, Charles N. Ellis, Margaret A. Connolly, Dr Sharon F. Levy

Published in: American Journal of Clinical Dermatology | Issue 1/2001

Login to get access

Abstract

Background

Topical clindamycin and benzoyl peroxide have each demonstrated clinical efficacy in the treatment of acne vulgaris. When used in combination, they promise greater efficacy than either individual agent used alone and the combined use of benzoyl peroxide with topical antibacterials has been shown to decrease the emergence of antibacterial resistant species.

Objective

The objective was to determine the efficacy and safety of a combination benzoyl peroxide plus clindamycin in a gel formulation compared with each of its 2 active constituents in gel vehicle, and gel vehicle given alone in the treatment of acne vulgaris.

Methods

In this 10-week, multicenter, double-blind trial, 480 patients with moderate to moderately severe acne were randomized to receive twice-daily treatment with 5% benzoyl peroxide plus 1% clindamycin, 5% benzoyl peroxide, 1% clindamycin, or vehicle.

Results

Significantly greater reductions in the number of inflammatory and total lesions were demonstrated in patients using combination therapy compared with those using any of its 3 individual components. Likewise, both physicians’ and patients’ global evaluations showed significantly greater improvements with the combination therapy than with its individual components. The most frequent adverse effect, dry skin, occurred to a similar extent in the combination and benzoyl peroxide treatment groups.

Conclusion

The improved efficacy obtained with the combination therapy was accompanied by a tolerability profile similar to that of benzoyl peroxide alone, making this new combination product an alternative antimicrobial therapy for acne vulgaris.
Literature
1.
go back to reference Chu A., Huber F.J., Plott R.T. 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; 136: 235–238PubMedCrossRef Chu A., Huber F.J., Plott R.T. 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; 136: 235–238PubMedCrossRef
2.
go back to reference Richter J.R., Forstrom L.R., Kiistala U.O., et al. Efficacy of the fixed 1.2 % clindamycin phosphate, 0.025% tretinoin gel formulation (Velac) and a proprietary 0.0 25% tretinoin gel formulation (Aberela) in the topical control of facial acne. J Eur Acad Dermatol Venereol 1998; 11: 227–233PubMed Richter J.R., Forstrom L.R., Kiistala U.O., et al. Efficacy of the fixed 1.2 % clindamycin phosphate, 0.025% tretinoin gel formulation (Velac) and a proprietary 0.0 25% tretinoin gel formulation (Aberela) in the topical control of facial acne. J Eur Acad Dermatol Venereol 1998; 11: 227–233PubMed
3.
go back to reference Korting H., Braun-Falco O. Efficacy and tolerability of combined topical treatment of acne vulgaris with tretinoin and erythromycin in general practice. Drugs Exp Clin Res 1989; 15: 447–451PubMed Korting H., Braun-Falco O. Efficacy and tolerability of combined topical treatment of acne vulgaris with tretinoin and erythromycin in general practice. Drugs Exp Clin Res 1989; 15: 447–451PubMed
4.
go back to reference Akamatsu H., Kurokawa I., Nishijima S., et al. Inhibition of neutrophil chemotactic factor production in comedonal bacteria by subminimal inhibitory concentrations of erythromycin. Dermatology 1992; 185: 41–43PubMedCrossRef Akamatsu H., Kurokawa I., Nishijima S., et al. Inhibition of neutrophil chemotactic factor production in comedonal bacteria by subminimal inhibitory concentrations of erythromycin. Dermatology 1992; 185: 41–43PubMedCrossRef
5.
go back to reference Webster G.F., Leyden J.J. Characterization of serum-independent polymorphonuclear leukocyte chemotactic factors produced by Propionibacterium acnes. Inflammation 1980; 4: 261–384PubMedCrossRef Webster G.F., Leyden J.J. Characterization of serum-independent polymorphonuclear leukocyte chemotactic factors produced by Propionibacterium acnes. Inflammation 1980; 4: 261–384PubMedCrossRef
6.
go back to reference Weiss J.S. Current options for the topical treatment of acne vulgaris. Pediatr Dermatol 1997; 14: 480–488PubMedCrossRef Weiss J.S. Current options for the topical treatment of acne vulgaris. Pediatr Dermatol 1997; 14: 480–488PubMedCrossRef
7.
go back to reference Esterly N.B., Furey N.L., Flanagan L.E. The effect of antimicrobial agents on leukocyte chemotaxis. J Invest Dermatol 1978; 70: 51–55PubMedCrossRef Esterly N.B., Furey N.L., Flanagan L.E. The effect of antimicrobial agents on leukocyte chemotaxis. J Invest Dermatol 1978; 70: 51–55PubMedCrossRef
8.
go back to reference Mills O.H., Kligman AM, Pochi P., et al. Comparing 2.5 %, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris. Int J Dermatol 1986; 25: 664–667PubMedCrossRef Mills O.H., Kligman AM, Pochi P., et al. Comparing 2.5 %, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris. Int J Dermatol 1986; 25: 664–667PubMedCrossRef
9.
go back to reference Tucker S., Tausend R., Cochran R. Comparison of topical clindamycin phosphate, benzoyl peroxide, and a combination of the two for the treatment of acne vulgaris. Br J Dermatol 1984; 110: 487–492PubMedCrossRef Tucker S., Tausend R., Cochran R. Comparison of topical clindamycin phosphate, benzoyl peroxide, and a combination of the two for the treatment of acne vulgaris. Br J Dermatol 1984; 110: 487–492PubMedCrossRef
10.
go back to reference Lookingbill D.P., Chalker D.K., Lindholm J.S., et al. Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel and vehicle gel: combined results of two double-blind investigations. J Am Acad Dermatol 1997; 37: 590–595PubMedCrossRef Lookingbill D.P., Chalker D.K., Lindholm J.S., et al. Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel and vehicle gel: combined results of two double-blind investigations. J Am Acad Dermatol 1997; 37: 590–595PubMedCrossRef
11.
go back to reference Chalker D.K., Shalita A., Smith J.G.I., et al. A double-blind study of the effectiveness of a 3% erythromycin and 5% benzoyl peroxide combination in the treatment of acne vulgaris. J Am Acad Dermatol 1983; 9: 933–936PubMedCrossRef Chalker D.K., Shalita A., Smith J.G.I., et al. A double-blind study of the effectiveness of a 3% erythromycin and 5% benzoyl peroxide combination in the treatment of acne vulgaris. J Am Acad Dermatol 1983; 9: 933–936PubMedCrossRef
12.
go back to reference Eady E.A., Bojar R.A., Jones C.E., et al. The effects of acne treatment with a combination of benzoyl peroxide and erythromycin on skin carriage of erythromycin resistant propionibacteria. Br J Dermatol 1996; 134: 107–113PubMedCrossRef Eady E.A., Bojar R.A., Jones C.E., et al. The effects of acne treatment with a combination of benzoyl peroxide and erythromycin on skin carriage of erythromycin resistant propionibacteria. Br J Dermatol 1996; 134: 107–113PubMedCrossRef
13.
go back to reference Borglund E., Hägermark Ö., Nord C.E. Impact of topical clindamycin and systemic tetracycline on the skin and colon microflora in patients with acne vulgaris. Scand J Infect Dis 1984; 43 Suppl.: 76–81 Borglund E., Hägermark Ö., Nord C.E. Impact of topical clindamycin and systemic tetracycline on the skin and colon microflora in patients with acne vulgaris. Scand J Infect Dis 1984; 43 Suppl.: 76–81
14.
go back to reference Eady E.A., Cove J.H., Holland K.T., et al. Erythromycin resistant Propionibacteria in antibiotic treated acne patients: Association with therapeutic failure. Br J Dermatol 1989; 121: 51–57PubMedCrossRef Eady E.A., Cove J.H., Holland K.T., et al. Erythromycin resistant Propionibacteria in antibiotic treated acne patients: Association with therapeutic failure. Br J Dermatol 1989; 121: 51–57PubMedCrossRef
15.
go back to reference Leyden J.J., McGinley K.J., Cavalieri S., et al. Propionibacteria acnes resistance to antibiotics in acne patients. J Am Acad Derm 1983; 8: 41–45PubMedCrossRef Leyden J.J., McGinley K.J., Cavalieri S., et al. Propionibacteria acnes resistance to antibiotics in acne patients. J Am Acad Derm 1983; 8: 41–45PubMedCrossRef
16.
go back to reference Eady E.A., Farmery M.R., Ross J.I., et al. Effects of benzoyl peroxide and erythromycin alone and in combination against antibiotic-sensitive and resistant skin bacteria from acne patients. Br J Dermatol 1994; 131: 331–336PubMedCrossRef Eady E.A., Farmery M.R., Ross J.I., et al. Effects of benzoyl peroxide and erythromycin alone and in combination against antibiotic-sensitive and resistant skin bacteria from acne patients. Br J Dermatol 1994; 131: 331–336PubMedCrossRef
17.
go back to reference Harkaway K., McGinley K.J., Foglia A.N., et al. Antibiotic resistance patterns in coagulase-negative staphylococci after treatment with topical erythromycin, benzoyl peroxide, and combination therapy. Br J Dermatol 1992; 126: 586–590PubMedCrossRef Harkaway K., McGinley K.J., Foglia A.N., et al. Antibiotic resistance patterns in coagulase-negative staphylococci after treatment with topical erythromycin, benzoyl peroxide, and combination therapy. Br J Dermatol 1992; 126: 586–590PubMedCrossRef
18.
go back to reference Pillsbury D.M. A manual of dermatology. Philadelphia, PA: W.B. Saunders, 1971 Pillsbury D.M. A manual of dermatology. Philadelphia, PA: W.B. Saunders, 1971
19.
go back to reference Nacht S., Yeung D., Jr Beasley J.N., et al. Benzoyl peroxide: Percutaneous penetration and metabolic disposition. J Am Acad Dermatol 1981; 4: 31–37PubMedCrossRef Nacht S., Yeung D., Jr Beasley J.N., et al. Benzoyl peroxide: Percutaneous penetration and metabolic disposition. J Am Acad Dermatol 1981; 4: 31–37PubMedCrossRef
20.
go back to reference Decker L.C., Deuel D.M., Sedlock D.M. Role of lipids in augmenting the antibacterial activity of benzoyl peroxide against Propionibacterium acnes. Antimicrob Agents Chemother 1989; 33: 326–330PubMedCrossRef Decker L.C., Deuel D.M., Sedlock D.M. Role of lipids in augmenting the antibacterial activity of benzoyl peroxide against Propionibacterium acnes. Antimicrob Agents Chemother 1989; 33: 326–330PubMedCrossRef
21.
go back to reference Kligman A., Leyden J.J., Stewart R. New use for benzoyl peroxide: A broad spectrum antimicrobial agent. Int J Dermatol 1977; 16: 413–417PubMedCrossRef Kligman A., Leyden J.J., Stewart R. New use for benzoyl peroxide: A broad spectrum antimicrobial agent. Int J Dermatol 1977; 16: 413–417PubMedCrossRef
Metadata
Title
Comparison of the Efficacy and Safety of a Combination Topical Gel Formulation of Benzoyl Peroxide and Clindamycin with Benzoyl Peroxide, Clindamycin and Vehicle Gel in the Treatments of Acne Vulgaris
Authors
James J. Leyden
Richard S. Berger
Frank E. Dunlap
Charles N. Ellis
Margaret A. Connolly
Dr Sharon F. Levy
Publication date
01-02-2001
Publisher
Springer International Publishing
Published in
American Journal of Clinical Dermatology / Issue 1/2001
Print ISSN: 1175-0561
Electronic ISSN: 1179-1888
DOI
https://doi.org/10.2165/00128071-200102010-00006

Other articles of this Issue 1/2001

American Journal of Clinical Dermatology 1/2001 Go to the issue

Original Research Article

Cyclosporine in Severe Psoriasis