DigniCap Scalp Cooling System

Minimize Hair Loss

Comfortably. Conveniently. Confidently.

Cancer patients undergoing chemotherapy have faced the almost inevitable prospect of losing their hair. While scalp cooling during chemotherapy has long been known as an effective method to help to prevent that hair loss, until recently patients in the U.S. did not have access to an FDA-cleared scalp cooling treatment.

In 2015 the FDA gave clearance to The DigniCap® Scalp Cooling System. It is now indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumor cancers.

For over a decade, DigniCap® has successfully helped thousands of patients outside the United States. Now, with FDA clearance, infusion centers across the country will be able to offer this important treatment option directly to U.S. patients as part of their chemotherapy treatment.

DigniCap® is already available in many infusion centers across the country, with more being added every week. Patients should talk with their physicians and infusion centers in their area to explore adding the DigniCap® treatment to their chemotherapy regimen.

Chemotherapy may destroy your cancer, but it doesn’t have to destroy your hair.

Hair Loss is Not Inevitable

Hair loss is a well-documented side effect of many chemotherapy drugs. Chemotherapy induced hair loss can be significantly reduced in many cases. The DigniCap® Scalp Cooling System offers you the possibility to keep all or most of your hair while receiving certain chemotherapy treatments for cancer from solid tumors. This may include breast cancer, ovarian cancer, prostate cancer and other solid tumor cancers.

For over a decade DigniCap has successfully helped thousands of patients outside the United States. Now, with FDA Clearance, we are proud to offer DigniCap as a treatment option for our patients.

What is DigniCap®?

Scalp Cooling – How It Works

The DigniCap® scalp cooling system consists of a snug-fitting silicone cooling cap connected to a cooling and control unit which circulates coolant through channels in the cap. Sensors in the cap monitor temperature on the scalp allowing the system to automatically regulate cooling temperature throughout the treatment. To make this process more comfortable, the cooling cap is at room temperature when placed on the head and the treatment temperature is gradually achieved over a short period of time. A separate safety sensor in the cap ensures that the scalp temperature always remains above 32°F/0°C. To ensure optimal treatment temperature, an outer insulating cap of neoprene is applied over the silicone cap.

Some chemotherapy drugs can damage your hair cells. Cooling of the scalp is a proven approach to reduce chemotherapy-induced hair loss that has been used successfully by tens of thousands of patients worldwide.

The reduced temperature results in a reduced blood flow to the scalp area so that less chemotherapy reaches the hair cells. Hair cells are therefore not exposed to the full dose of chemotherapy and may be able to survive the chemotherapy treatment. In addition, cellular metabolism within the hair cells is slowed down. As a result, hair is less likely to fall out.

Who Can Use DigniCap?

The DigniCap® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced in patients with solid tumors. Please note that scalp cooling is effective with many chemotherapy drugs, but not all. Your clinician can tell you if scalp cooling is compatible with your treatment.

Clinical Research Summary

The DigniCap® scalp cooling system was studied in women with breast cancer at some of the most prestigious medical centers in the nation. In the pivotal trial it was concluded that the scalp cooling system, DigniCap,® prevented hair loss in 66.3% of patients with breast cancer receiving adjuvant chemotherapy compared to control where all experienced significant hair loss. Treatment was well tolerated with no scalp metastases observed. The DigniCap® scalp cooling system was found to be highly effective in reducing chemotherapy-induced alopecia.

The DigniCap® Scalp Cooling System was cleared for use in the United States by the FDA on 12/8/2015 for female breast cancer patients being treated with chemotherapy, the first such device to receive clearance. The FDA expanded the clinical indications for DigniCap on 7/3/17 to now include men and women with solid tumors.