| The U.S. Food and Drug Administration | | | | lesions |
| (FDA) states its purpose in the | | | | (* worsening beyond Grade 4 is |
| following mission statement: | | | | possible). |
| "The FDA is responsible for protecting | | | | Acne Drug Treatment Study Groups |
| the public health by assuring the | | | | Acne drug test groups should be large |
| safety, efficacy, and security of human | | | | enough to be statistically significant |
| and veterinary drugs, biological | | | | so that any claims of success and safety |
| products, medical devices, our nation's | | | | can be supported. Test patients are |
| food supply, cosmetics, and products | | | | usually recruited during their most |
| that emit radiation. The FDA is also | | | | severe acne breakouts. |
| responsible for advancing the public | | | | Acne drug trials are recommended to be |
| health by helping to speed innovations | | | | randomized, blinded, multicenter trials, |
| that make medicines and foods more | | | | and other requirements will also apply. |
| effective, safer, and more affordable; | | | | A control or placebo group should be |
| and helping the public get the accurate, | | | | utilized. |
| science-based information they need to | | | | Furthermore, those doing testing should |
| use medicines and foods to improve their | | | | recruit test populations that are |
| health." | | | | representative of the age, race, gender, |
| In 2005 the FDA provided a public draft | | | | and geographic location of acne patients |
| guidance document to the pharmaceutical | | | | in the United States. |
| industry on the development of drugs to | | | | Determining The Success Of Acne Drug |
| treat acne vulgaris, or acne. The draft | | | | Treatments |
| guidance document contains the FDA's | | | | Acne severity is rated at the beginning |
| current thinking on the development of | | | | and end of every test. Photographic |
| acne drugs and the methods that should | | | | evidence and/or lesion counts may also |
| be used. | | | | be taken. It is proposed to measure the |
| Some of the guidance document | | | | success of acne medications as either a |
| information is summarized below. At the | | | | success or a failure, based on one of |
| time of this writing the FDA document | | | | these two methods of measuring success: |
| had not been finalized. | | | | 1. Success meaning a rating of clear |
| Types of Acne Lesions | | | | skin or almost clear (severity rating 0 |
| The two major types of acne lesions are | | | | or 1) within the test period; or |
| classified as non-inflammatory and | | | | 2. Success meaning an improvement of 2 |
| inflammatory. Non-inflammatory acne | | | | severity grades within the test period. |
| lesions are more commonly known as | | | | Under this definition, a successful test |
| whiteheads and blackheads. Inflammatory | | | | subject would have a severity |
| acne lesions include papules and | | | | improvement from 4 to 2 within the test |
| pustules and are more deeply seated in | | | | period, as an example. |
| the skin than the non-inflammatory | | | | The Final Decision On New Acne Drugs |
| lesions. | | | | Several phases of testing are |
| How Acne Severity Is Rated | | | | recommended for proposed acne drugs. |
| Currently there is no standardized | | | | Studies must be designed to account for |
| method for rating the severity of acne | | | | effects such as test dropouts. Rigorous |
| outbreaks. Several methods have been | | | | data analysis must be performed in |
| proposed, but each has its difficulties. | | | | conformance with FDA regulations. Only |
| A sample scale for rating acne severity | | | | acne drug test data that has been |
| is summarized below, from least to most | | | | validated and undergone quality |
| severe: | | | | assurance testing should be submitted to |
| 0 Clear skin with no inflammatory or | | | | the FDA for approval. |
| non-inflammatory lesions | | | | Only through a rigorous and |
| 1 Almost clear; rare non-inflammatory | | | | tightly-controlled testing and analysis |
| lesions with no more than one small | | | | procedure, followed by FDA approval, can |
| inflammatory lesion | | | | new acne drugs be made available to the |
| 2 Mild severity; greater than Grade 1; | | | | public. |
| some non-inflammatory lesions with no | | | | The resource link below contains free |
| more than a few inflammatory lesions | | | | information on the best ways to utilize |
| (papules/pustules only, no nodular | | | | FDA-approved prescription and over the |
| lesions) | | | | counter acne drugs and treatments. |
| 3 Moderate severity; greater than Grade | | | | Source: Guidance for Industry, Acne |
| 2; up to many non-inflammatory lesions | | | | Vulgaris: Developing Drugs for |
| and may have some inflammatory lesions, | | | | Treatment, DRAFT GUIDANCE, U.S. |
| but no more than one small nodular | | | | Department of Health and Human Services, |
| lesion | | | | Food and Drug Administration Center for |
| 4* Severe; greater than Grade 3; up to | | | | Drug Evaluation and Research (CDER), |
| many non-inflammatory and inflammatory | | | | September 2005, Clinical/Medical. |
| lesions, but no more than a few nodular | | | | |