Retin-A Micro (tretinoin gel) microsphere, 0.1%, was also significantly superior to the vehicle in the investigator's global evaluation of the clinical response. In Study #1, thirty-five percent (35%) of patients using Retin-A Micro (tretinoin gel) microsphere, 0.1%, achieved an excellent result, as compared to eleven percent (11%) of patients on the vehicle control. In Study #2, twenty-eight percent (28%) of patients using Retin-A Micro (tretinoin gel) microsphere, 0.1%, achieved an excellent result, as compared to nine percent (9%) of the patients on the vehicle control.

Retin-A Micro (tretinoin gel) microsphere, 0.04%: In two vehicle-controlled clinical studies, Retin-A Micro (tretinoin gel) microsphere, 0.04%, applied once daily was more effective (p< 0.05) than vehicle in reducing the acne lesion counts. The mean reductions in lesion counts from baseline after treatment for 12 weeks are shown in the following table:

Retin-A Micro (tretinoin) microsphere, 0.04%, was also superior (p< 0.05) to the vehicle in the investigator's global evaluation of the clinical response. In study #1, fourteen percent (14%) of patients using Retin-A Micro (tretinoin gel) microsphere, 0.04%, achieved an excellent result compared to five percent (5%) of patients on vehicle control. In study #2, nineteen percent (19%) of patients using Retin-A Micro (tretinoin gel) microsphere, 0.04%, achieved an excellent result compared to nine percent (9%) of patients on vehicle control.

No studies were conducted comparing the efficacy of Retin-A Micro 0.04% to Retin-A Micro 0.1%. There is no evidence that Retin-A Micro 0.1% is more efficacious than Retin-A Micro 0.04% or that Retin-A Micro 0.04% is safer than Retin-A Micro 0.1%.

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