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Adding Adapalene Gel to Clindamycin Helps Patients with Acne Vulgaris: Presented at WCD

By Jill Stein
Special to DG News

PARIS, FRANCE -- July 3, 2002 -- Adapalene 0.1 percent gel significantly enhances the benefits of topical clindamycin lotion in patients with acne vulgaris, researchers said here on July 2nd at the 20^th World Congress of Dermatology (WCD).

Dr. David Kaplan, with Adult and Pediatric Dermatology, Overland Park, Kansas, United States, and colleagues conducted a multicentre, randomised, investigator-blinded, parallel comparison of clindamycin topical lotion, applied twice daily, plus adapalane 0.1 percent gel or gel vehicle, applied once daily, to determine whether an enhanced effect exists with the combination.

The study enrolled 249 patients aged 12 years or older with mild to moderate acne vulgaris; Patients had 10 to 50 inflammatory lesions, 20 to 150 non-inflammatory lesions, and a global acne severity grade between 2 and 8 on the Leeds revised acne grading system.

Patients were randomised to either clindamycin 1 percent lotion and adapalene 0.1 percent gel or clindamycin lotion and adapalene gel vehicle. In the morning, they applied clindamycin lotion. In the evening, they applied the gel and two minutes later they applied clindamycin lotion.

Study products were applied to the face for 12 weeks. Subjects were evaluated at baseline and at weeks 2, 4, 8, and 12.

Results showed that improvement from baseline in total lesion counts, inflammatory lesion counts, non-inflammatory lesion counts, and global severity grade at week 12 were all significantly greater with the clindamycin -adapalene combination (p<0.001).

After 12 weeks of treatment, there was an almost twofold greater decrease in total lesion counts for the adapalene group than for the vehicle control group (46.7 percent versus 25.5 percent).

The difference in total and non-inflammatory lesion counts between the two groups was observed as soon as week 2.

The secondary efficacy analysis for global severity grade was statistically significant beginning at week 8 and maintained statistical significance through week 12 in favor of clindamycin-adapalene combination.

At week 12, subjects treated with the clindamycin-adapalene combination reported less erythema than subjects in the vehicle group; there was no difference between the two groups with respect to local tolerance except for erythema. Overall, the incidence of adverse events was comparable in the two treatment groups.

In addition to the expected effect of a retinoid on non-inflammatory lesions, adapalene has a significant anti-inflammatory effect that enhances the therapeutic action of clindamycin on inflammatory acne lesions, Dr. Kaplan said.

The significantly larger and faster effect on acne lesions obtained by adding adapalene to clindamycin indicates that this combination can be used at the onset of therapy, with no significant tolerability burden, to obtain a better clinical response than that obtained by using the antibiotic alone, he added.

The study was sponsored by Galderma R & D in Cranbury, New Jersey.

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