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Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Dermatology | Family Medicine

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Retin-A Micro (tretinoin gel) microsphere, 0.1%

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Advanced Polymer Systems
Approval Status: Approved February 1997
Treatment Area: acne

General Information

Retin-A Micro has been approved for the treatment of acne vulgaris. The new acne treatment entraps tretinoin, the active ingredient in RETIN-A, in Microsponge systems (round microscopic particles made of synthetic polymer) and formulates them into a gel. The microspheres hold the medication in reserve, allowing the skin to absorb small amounts of tretinoin over time. Dermatologists who conducted the pivotal clinical studies believe this may be why most RETIN-A MICRO patients experience little or no irritation. The microspheres themselves remain on top of the skin and are easily washed off when patients shower or wash their faces.

Clinical Results

In comparison studies involving approximately 700 patients, Retin-A Micro had demonstrated efficacy in the treatment of acne. In patients with sensitive skin, the unique new gel was significantly less irritating that 0.1% tretinoin cream when applies to opposite facial cheeks in a double-blind study. The lower irritancy of Retin-A Micro is believed to be attributable to the design of its vehicle containing patented Microsponge systems.

Side Effects

Of those using RETIN-A MICRO, 90 percent experienced no or mild erythema (redness), 84 percent experienced no or slight peeling, 88 percent experienced no or slight burning/stinging, and 91 percent experienced no or slight itching at two weeks - the typical peak irritation period for tretinoin.