How New Acne Drugs Are Developed
0 Clear skin with no inflammatory or non-inflammatory lesions1 Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion2 Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)3 Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion4* Severe; greater than Grade 3; up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions(* worsening beyond Grade 4 is possible).Acne Drug Treatment Study GroupsAcne drug test groups should be large enough to be statistically significant so that any claims of success and safety can be supported. Test patients are usually recruited during their most severe acne breakouts.Acne drug trials are recommended to be randomized, blinded, multicenter trials, and other requirements will also apply. A control or placebo group should be utilized.Furthermore, those doing testing should recruit test populations that are representative of the age, race, gender, and geographic location of acne patients in the United States.Determining The Success Of Acne Drug TreatmentsAcne severity is rated at the beginning and end of every test. Photographic evidence and/or lesion counts may also be taken. It is proposed to measure the success of acne medications as either a success or a failure, based on one of these two methods of measuring success1. Success meaning a rating of clear skin or almost clear (severity rating 0 or 1) within the test period; or2. Success meaning an improvement of 2 severity grades within the test period. Under this definition, a successful test subject would have a severity improvement from 4 to 2 within the test period, as an example.The Final Decision On New Acne DrugsSeveral phases of testing are recommended for proposed acne drugs. Studies must be designed to account for effects such as test dropouts. Rigorous data analysis must be performed in conformance with FDA regulations. Only acne drug test data that has been validated and undergone quality assurance testing should be submitted to the FDA for approval.Only through a rigorous and tightly-controlled testing and analysis procedure, followed by FDA approval, can new acne drugs be made available to the public.The resource link below contains free information on the best ways to utilize FDA-approved prescription and over the counter acne drugs and treatments.Source Guidance for Industry, Acne Vulgaris Developing Drugs for Treatment, DRAFT GUIDANCE, U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER), September 2005, Clinical/Medical.
How New Acne Drugs Are Developed
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