Avita

CLINICAL PHARMACOLOGY

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, Tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Pharmacokinetics

In vitro and in vivo pharmacokinetic studies with AVITA® Gel indicate that less than 0.3% of the topically applied dose is bioavailable. Circulating plasma levels of both Tretinoin and isotretinoin are only slightly elevated above those found in healthy normal controls.

Clinical Studies

In two large vehicle-controlled clinical trials, AVITA® (Tretinoin gel) Gel 0.025%, applied once daily was more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity. Percent reductions in lesion counts after treatment for 12 weeks in these studies are shown in the following Tables:

Study 1 AVITA®Gel, 0.025 %
N = 198
Vehicle Gel
N = 204
Noninflammatory Lesions -36% -27%
Inflammatory Lesions -35% -25%
Total Lesions -36% -27%
Study 2 AVITA®Gel, 0.025 %
N=58
Vehicle Gel
N = 58
Noninflammatory Leaions -42% -26%
Inflammatory Lesions -38% -23%
Total Lesions -41% -26%
N = Number of Subjects

Last reviewed on RxList: 8/18/2011
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD