We are an independent, community based clinical trials’ research center devoted to conducting clinical trials. Conveniently located near LAX airport, we have been hosting dermatological trials in the Los Angeles area for nearly 10 years. We are constantly looking for patients with psoriasis, atopic dermatitis (or eczema), acne, and fungus, who are interested in participating.
What is a clinical trial?
FDA. This begins with years of experiments in animal and human cells, followed by testing in animals. If these tests are successful, a pharmaceutical company requests permission from the FDA to begin testing the drug in humans. These tests are called clinical trials and they exist in several phases.
Phase I Trials
Phase I trials are primarily concerned with assessing the drug’s safety. The study is designed to address how much of the drug can be given safely and what happens to the drug in the human body—how is it absorbed, metabolized, and excreted. Phase I studies investigate side effects that occur as dosage levels increase.
Phase II Trials
After a drug has been proven safe, testing focuses on efficacy (effectiveness). Phase II studies compare the effects of the drug between other “standard treatments” and a placebo (a treatment with no active ingredient). If a placebo is in use, these studies are generally “double blind”, so that neither the patient nor the physician knows if the patient is receiving the medication. This phase of testing may last from several months to two years.
Phase III Trials
After establishing the safety and efficacy of the medication, the drug is tested on a much wider scale to provide a more thorough understanding of the drug’s effectiveness, benefits, and the range of possible adverse reactions. Whereas Phase II studies typically involve a few hundred patients, Phase III studies often involve between several hundred and several thousand patients. At the completion of a Phase III trial, the pharmaceutical company can request FDA approval for marketing of the drug.
Phase IV Trials
Phase IV trials may be performed after the drug or treatment is already approved for use by the FDA. These studies can compare the new drug to specific existing treatments, look for long-term side-effects, or examine the cost-effectiveness of the drug therapy.