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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