Retin-A Micro Now Available by Prescription
RARITAN, N.J., March 18

A gentler form of the popular acne treatment Retin-A(R) (retinoin) is now available by prescription. Retin-A Micro(TM) (retinoin gel) microsphere, 0.1%, the first prescription product to utilize Microsponge(R) technology, minimizes the irritation commonly experienced by patients using the highest strength of Retin-A.
Retin-A Micro is indicated for the topical treatment of acne vulgaris. The new medication, cleared for marketing by the U.S. Food and Drug Administration (FDA) on February 7, 1997, uses Advanced Polymer System's technologically advanced Microsponge system to deliver the maximum strength of Retinoin with minimal irritation. The product is marketed by Ortho Dermatological.
The new acne treatment entraps retinoin, 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 retinoin 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.
"The advantage to acne patients, particularly those with sensitive skin, is that they get a full-strength Retin-A therapy with a favorable irritation profile," says Guy Webster, M.D., Associate Professor, Director of the Center for Cutaneous Pharmacology, Jefferson Medical College, and a clinical investigator in one of the pivotal Retin-A Micro studies. "Acne sufferers using Retin-A Micro should not experience the same level of skin reactions as has been seen with the higher strengths of Retin-A in the past."
Another of the medication's benefits could lead to improved compliance, adds Dr. Webster. "Retin-A Micro can be applied immediately after patients wash their face, unlike the 20-30 minute waiting period for Retin-A."
Retin-A Micro was not compared to Retin-A in clinical acne trials, however, clinical safety and efficacy esults appear consistent with results observed with other forms of Retin-A. In clinical studies, Retin-A Micro was studied against placebo for efficacy and tolerability.
Of those using Retin-A Micro, 90% experienced no or mild erythema (redness), 84% experienced no or slight peeling, 88% experienced no or slight burning/stinging, and 91% experienced no or slight itching at two weeks -- the typical peak irritation period for retinoin.
The irritancy of Retin-A Micro was compared to Retin-A 0.1% cream in a double-blind study in which the two medications were applied to opposite facial cheeks of women (ages 24-45) with sensitive skin, but without acne. Retin-A Micro was significantly better tolerated and preferred by patients in this study. In addition to a reduced irritation profile and its easy application regimen, patients currently using Retin-A will notice some differences with the new product. Retin-A Micro is an acetone-free, alcohol-free aqueous gel with microspheres. The microspheres have an opaque powder appearance and cause the gel to look more like a cream. Its yellow appearance is primarily a result of the active ingredient, retinoin, which is a yellow crystalline powder.
Therapeutic results with Retin-A Micro may be noticed after two weeks, but up to seven weeks of therapy may be required before consistent beneficial effects are observed. Retin-A Micro significantly improved patients' acne by 12 weeks in clinical studies.
Retinoin, the active ingredient in Retin-A Micro and Retin-A, can also be found in Renova(R) (retinoin emollient cream) 0.05%. But while Retin-A and Retin-A Micro are formulated for acne-prone skin, Renova is a rich emollient cream developed specifically for treating fine wrinkles, brown spots and surface roughness.

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