Cosmetic dermatology and the "none" or "almost none" phenomenon
We are entering a new era in dermatology where numerous drugs are available with the sole purpose of improving appearance and not treating disease. Certainly, aging could be considered a disease that affects all humans, but it is possible to argue that since all humans age, it is normal and not a disease.
Whether the appearance degradation of aging is normal or a disease, the neurotoxins that are being used to treat the condition are considered drugs and are studied and examined for safety in the same manner as all drugs designed to treat disease. This is exemplified by most recent draft guidance issued in August 2014 by the FDA on Upper Facial Lines: Developing Botulinum Toxin Drug Products. This guidance states that for a neurotoxin to be approved as efficacious, it must remove all motion in the injection area receiving a rating in the category of “none” or zero. While this is quite desirable in the glabellar area, where frowning is almost always considered an unattractive facial expression, it might not be desirable to eliminate all movement around the eyes, a common area of neurotoxin injection. Many have observed that failure of skin movement around the eyes when smiling leads to the perception by others of insincerity. Indeed, some contraction of the skin around the eyes when smiling is normal since the lower eye contracts simultaneously with the corner of the mouth, which produces lifting of the mouth corner and smiling.