FDA and Hair Transplantation

FDA is an important institution in terms of assuring the reliability and effectiveness of the treatment methods used in the health sector. Medicines and medical devices used in the treatment of hair loss are subject to a strict FDA approval process.

How Does the FDA Approval Process Work?

Working under the United States Department of Health, the FDA considers three main factors before approving the use of all drugs and medical devices.

1. Target condition and appropriate treatments

• Benefits and risks from clinical data
• Risk management strategies

The FDA approval process consists of 4 important stages: Preclinical, Clinical, Confidentiality and marketing. The most demanding stages of the approval process are the preclinical and clinical research processes.

1. Preclinical Research Phase:

The first stage of the process is exploration and screening. When a drug is developed, it is first tested on animals. Along with the test results, drug manufacturers and sponsors submit applications for New Research-Based Drugs.

2. Clinical Stage:

The clinical phase consists of the process of more in-depth testing, during which clinical trials of the drug are carried out. At this stage, the procedure for testing drugs works as follows:  

• Testing the drug on a small group of health volunteers (less than 100 people) and observing how and how it is excreted from the body
• Testing the drug on larger groups (100 to 1000 people) to observe its effectiveness
• Testing on even more participants (1000s) factors such as safety, efficacy, dosage, interaction with different drugs, how and how it may affect different populations

After these processes are completed, the FDA reviews the manufacturer’s application. The final test that the approved drug must pass before it takes its place on the shelves is the labeling and production facility inspection. After the drug is approved and released, the manufacturer or sponsor is required to periodically share the drug’s safety and efficacy data with the FDA.

Minoxidil

Minoxidil, currently on the market under the brand name rogaine, is an over-the-counter topical medication developed to slow hair loss and accelerate hair growth. The effects of the drug in terms of helping hair growth were first discovered in the early 80s. Known as Rogaine, the drug was approved by the FDA in 1988. The principle of minoxidil’s effect on the hair is to support the hair follicles. Minoxidil is a reliable treatment option for women and men with hair loss problems.

Propecia (Finasteride)

It is a drug used in the treatment of male pattern hair loss, which is not very serious. DHT hormone is considered to be responsible for male pattern hair loss. Prospecia acts on hair loss by inhibiting the enzyme responsible for DHT production. However, DHT blockers such as propecia have the potential to cause sexual problems such as aversion to sexual desire and the inability to get or maintain an erection. While these side effects can be seen during the use of the drug, they may continue for a while after the drug is discontinued. The use of this drug in women is considered undesirable in the reproductive age due to the risk that it may prevent the development of the male fetus.

Hair Transplant

Hair transplantation is not a method that treats the causes of hair loss. The main goal in hair loss problems is to treat the underlying causes. Hair transplantation is preferred in order to eliminate the psychological problems caused by hair loss. There are different techniques that can be safely preferred in hair transplantation:

FUE, FUT, Neograft, ARTAS, FAT Hair Transplantation

Neograft, which is a semi-automatic hair transplant technique, is also a different version of the FUE technique. In hair transplantation operations performed using the FUE technique, hair follicles are taken one by one from the donor area and transferred to the balding area. Another technique applied in hair transplantation is the FUT method. FUT is performed by removing the scalp from the donor area in strips and transferring it to the balding area. FUE technique; It is more advantageous than the FUT technique in that it causes less scarring, has fewer side effects and results in a more natural appearance. The neograft, which has the FUE technique, has been approved by the FDA.

Artas is an application with a wider technology among hair transplantation techniques. As mentioned above, neograft is a semi-automatic hair transplant technique. In other words, it has the feature of being controlled by the surgeon who performs the hair transplantation. In Artas hair transplantation technique, the process is applied by automatic hair transplantation robots. Artas was approved by the FDA in 2011.

FAT Hair transplantation is the method of FUE Hair transplantation, which is performed by taking a piece of oil from the patient, injecting the oil into the hairless area after enriching it with stem cells. The aim here is to revitalize the balding and unhealthy scalp in order to bleed it and make it ready for transplantation.

Which Technique Is Best?

Well, which hair transplant technique is better? The subject completely depends on the patient and the experience of the hair transplant specialist.

Low Level Laser Therapy

With this method, it is aimed to stimulate the hair follicles and to grow and reproduce the hair. As a result of the researches, it was found that it is effective on male pattern hair loss. Low Level Laser Therapy is performed with FDA approved devices.

Future Treatment Opportunities

Hair loss is one of the common and common problems of many women and men around the world. In this respect, hair loss treatment technology is constantly developing and renewing. Studies are continuing on many treatment methods that have not been approved by the FDA and are in the process of getting approval.