New Retin-A Formulation
The U.S. Food and Drug
Administration (FDA) finally granted marketing
approval for Retin-A Micro 0.04% (tretinoin
gel) microsphere, which was a new, lower-strength
formulation of Retin-A Micro (tretinoin gel)
microsphere, a popular topical acne treatment.
Basically, new Retin-A Micro
0.04% presents a variation in the dosage strength
of Retin-A Micro, used for the treatment of
acne vulgaris. It makes use of a patented Microsponge
delivery system – the final product being
a water-based, cosmetically sophisticated formulation
containing 0.04% tretinoin (the vitamin A acid).
When studies were conduced
to test the efficacy of this product in comparison
with older formulations, it was found that the
new Retin-A 0.04% did considerably lessen non-inflammatory
and inflammatory acne lesions but at the same
time, caused lesser irritation and thus, a higher
level of tolerability.
Clinical investigators affirmed
the high satisfaction levels which patients
associated with upon usage of this product.
Two major clinical trials
were held with a total of 282 patients. The
results showed that Retin-A Micro 0.04% caused
a reduction in inflammatory lesions by 45%,
a reduction in non-inflammatory lesions by 35%
and an impressive 39% reduction in the total
lesion occurrence.
These results could be observed
even as early as 2 weeks, which is considerably
remarkable, and the complete curative effects
after 7 weeks and beyond. It was only around
1% of the total group of patients who complained
of excessively irritated skin.
Retin-A
Micro 0.04% has managed to achieve these
impressive results due to its use of A. P. Pharma's
unique, Microsponge delivery system, which keeps
a reserve of tretinoin to provide more tolerability
but not at the expense of reduced effectiveness
(FDA Approves Second Formulation Of Ortho Neutrogena's
Retin-A Micro For U.S. Market).
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