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
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.
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
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.