Researchers want to find out more about an investigational drug called ATI-50002 Topical Solution. An “investigational” drug is a drug that is being tested as a potential treatment and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Alopecia is the general medical term for hair loss. Alopecia areata (AA) starts as mild patchy hair loss, but can progress. Severe AA occurs in two forms: alopecia totalis (AT) which is total hair loss on the scalp (head), or alopecia universalis (AU) which is hair loss of the scalp and the rest of the body including eyebrows and eyelashes.
Alopecia areata is an autoimmune disease. Your body’s immune system protects you from disease and infection, but if you have an autoimmune condition or disease, your immune system attacks healthy cells in your body by mistake. In AA, the immune system attacks the hair follicles.
Currently, there is no proven treatment for AA. Increases in the understanding of what causes AA has led to the development of the new drug ATI-50002, which may help to stop the body from attacking the hair follicles, which causes hair to stop growing and fall out.
The main purpose of this study is to see whether two strengths of ATI-50002 Topical Solution (0.46% and 0.12%) can help regrow hair in people with stable patchy alopecia areata. Researchers also want to find out if the two strengths of ATI-50002 Topical Solution are safe and tolerable.
This study will compare the two strengths of ATI-50002 Topical Solution with a placebo solution to see if using ATI-50002 Topical Solution is better than using a placebo solution. The placebo solution is a substance that looks like ATI-50002 Topical Solution, but has no drug in it.
It is planned that about 120 people with stable patchy alopecia areata will be in this study.
If you decide to be in this study, you might have to stop using your regular medication or therapy during the entire study.
The study doctor or study staff will give you study drug to put on your scalp. You will apply up to 4 mLs of the study drug 2 times a day (in the morning and evening approximately 12 hours
apart) for 12 weeks.
You will be assigned by chance (like flipping a coin) to 1 of the following study groups:
Group 1: ATI-50002 Topical Solution, 0.46%
Group 2: ATI-50002 Topical Solution, 0.12%
Group 3: Placebo Solution (a substance that looks like a drug, but has no drug in it)
You have an equal chance of being in any of the study groups.
Neither you nor the study doctor or study staff will be able to pick which study group you are in. You will not know and the study doctor or study staff will not know which study group you are in.
The study doctor or study staff can find out if it is necessary to know for your health. If this happens, the study doctor or study staff may not be able to tell you which study group you were
in until everyone finishes the study.
While you are in the study, you must:
Follow the instructions you are given.
Come to the study center for all visits with the study doctor or study staff.
Tell the study doctor or study staff about any changes in your health or the way you feel.
Tell the study doctor or study staff if you want to stop being in the study at any time.