Clindoxyl® Gel For The Treatment Of Acne Vulgaris

J.K.L. Tan, MD, FRCPC

University of Western Ontario, and the Acne Research and Treatment Center, Windsor, ON, Canada

ABSTRACT

Clindoxyl® Gel (Stiefel) is a combination of 1% clindamycin phosphate and 5% benzoyl peroxide in a gel vehicle that is well tolerated and more efficacious than either active agent alone or the vehicle in reducing lesion counts and improving global scores in patients with moderate acne. It was approved for once daily use in Canada in November 2001.

Key Words:
management, metronidazole, rosacea

Topical agents such as clindamycin, erythromycin and benzoyl peroxide have been mainstays in the treatment of acne vulgaris for the past two decades. Previous studies have demonstrated that the combination of erythromycin and benzoyl peroxide was more effective than either agent used alone.^1,2 This article reviews the pivotal studies for Clindoxyl® Gel, a combination of 1% clindamycin phosphate and 5% benzoyl peroxide that is supplied in a ready-to-use tube, so compounding is not necessary.

Indications and Clinical Use

Clindoxyl® Gel was approved by TPP Canada in November 2001, and is indicated in the topical treatment of moderate acne vulgaris characterized by comedones and papulopustules.

This product is contraindicated in patients with a history of hypersensitivity to products containing clindamycin, lincomycin, benzoyl peroxide or any other component of the preparation. Relative contraindications also include: a history of regional enteritis, ulcerative colitis, or antibioticassociated colitis.

Review of Clinical Studies Trials

Three pivotal, randomized, controlled, double-blind trials were performed with Clindoxyl® Gel involving a total of 673 patients.³ Results from two of these studies have previously been reported.⁴ Inclusion criteria in all 3 studies included facial acne vulgaris with a minimum of 12 comedones, 12 papules and/or pustules, and a maximum of 3 nodulocysts. Patients were randomized to receive Clindoxyl®, clindamycin, benzoyl peroxide, or vehicle gel and instructed to apply the study medication to the entire face once daily in the evening for 11 weeks. Efficacy evaluations comprised lesion counts and investigator global assessments.

In all studies, no significant differences in demographic features or lesional counts were noted between treatment groups at baseline.

A summary of results from pooling the data from the 3 studies is shown in Table 1. Clindoxyl® demonstrated a significantly greater reduction of non-inflammatory lesions than clindamycin and vehicle groups (with P values ranging from 0.000-0.037) at 11 weeks. Furthermore, Clindoxyl® was significantly more effective than the vehicle at reducing inflammatory lesions at week 11. Pooling data from the 3 studies demonstrated that Clindoxyl® treated patients had a significantly greater mean and percent reduction in total lesion counts, and greater mean global improvement scores at week 11 when compared to the other treatment groups.

Summary

Clindoxyl® Gel, a combination of 1% clindamycin phosphate and 5% benzoyl peroxide, is efficacious and well tolerated in the treatment of moderate acne vulgaris. Furthermore, this combination product is more efficacious than either agent individually.

References

1. Shalita AR, Chalker DK, Ellis CN, et al. A multicenter, double-blind, controlled study of the combination of erythromycin/benzoyl peroxide, erythromycin alone, and benzoyl peroxide alone in treatment of acne vulgaris. Cutis 49:1-4 (1992).
2. Chalker DK, Shalita A, Smith JG Jr, Swann RW. 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 9(6):933-6 (1983 Dec).
3. Clindoxyl Gel-NDS Comprehensive Summary. Stiefel Canada Inc, Data on File.
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 gel and vehicle gel: Combined results of two doubleblind investigations. J Am Acad Derm 37(4):590-5 (1997 Oct).