The U.S. Food and Drug Administration (FDA) states its purpose in the following mission statement:
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and another affordable; connective helping the public get the accurate, science-based information they need to use medicines et cetera foods to improve their health.”
In 2005 the FDA provided a public draft guidance document to the pharmaceutical industry on the development from drugs to treat acne vulgaris, or acne. The draft guidance document contains the FDA’s current thinking on the development of acne drugs et cetera the methods that should be used.
Some of the guidance document facts is summarized below. At the time of this writing the FDA document had not been finalized.
Types of Acne Lesions
The two major types of acne lesions are classified as non-inflammatory and inflammatory. Non-inflammatory acne lesions are more commonly known as whiteheads and blackheads. Inflammatory acne lesions include papules and pustules and are more deeply seated in the skin than the non-inflammatory lesions.
How Acne Severity Is Rated
Currently there is refusal standardized virtuosity for rating the severity of acne outbreaks. Several methods have bot proposed, but each has its difficulties. A illustration scale for rating acne severity is summarized below, from least to most severe:
0 Clear skin with no inflammatory or non-inflammatory lesions
1 Almost clear; rare non-inflammatory lesions with no more than one picayune inflammatory lesion
2 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; jump to many non-inflammatory lesions and may have some inflammatory lesions, but no also than one small nodular lesion
4* Severe; greater than Grade 3; up to many non-inflammatory and inflammatory lesions, but disagree more than a few nodular lesions
(* worsening beyond Grade 4 is possible).
Acne Drug Treatment Eye Groups
Acne dope examine groups should be large fully to be statistically significant so that any claims about success ampersand touchback 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, furthermore 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 Narcotize Treatments
Acne 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 calculate the success of acne medications essentially either a success or a failure, based on one of these two methods of measuring success:
1. Success meaning a rating of clear skin or almost clear (severity rating 0 alternative 1) within the test period; or
2. 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 Drugs
Several phases of testing are recommended for proposed acne drugs. Studies want be designed to account for effects such as test dropouts. Rigorous information analysis must be performed in conformance with FDA regulations. Only acne drug test data that has been validated plus 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, vessel neoteric acne drugs be made attainable to the public.
The resource link below contains free information on the best ways to avail 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 Marijuana Evaluation moreover Research (CDER), September 2005, Clinical/Medical.