PIVOTAL TRIAL – CLINICAL STUDY IN STAGE I AND II BREAST CANCER 

In 2015, after a rigorous review by the FDA, DigniCap was the first scalp cooling system to receive clearance in the United States. Summary It was concluded that the DigniCap Scalp Cooling System prevented hair loss in 66.3% of patients with breast cancer receiving adjuvant chemotherapy, compared to a control group where all patients experienced significant hair loss. Scalp cooling treatment was well-tolerated and no scalp metastases have been observed.

For more information about the DigniCap Pivotal Trial CLICK HERE.

To read the 2023 Long Term Safety Study, CLICK HERE

To review the 2018 preliminary Long-term Safety Follow-Up CLICK HERE.

ANTHRACYCLINES

An Italian study published in 2019 assessed the effectiveness of scalp cooling with DigniCap for patients receiving adjuvant chemotherapy with an anthracycline with or without taxanes. DigniCap was able to prevent significant hair loss in 43% of breast cancer patients receiving adjuvant chemotherapy.

For more information about the DigniCap and anthracyclines CLICK HERE.

RESEARCH OVERVIEW – SOLID TUMORS

As published in numerous academic journals, The DigniCap Scalp Cooling System has been shown to be safe and effective in reducing chemotherapy-induced alopecia in cancer patients with solid tumors.

Of 226 patients with various solid tumors and undergoing different chemotherapies 65% showed no visible hair loss.

For more information about research on solid tumors, CLICK HERE.

RESEARCH OVERVIEW – SCALP METASTASES

Metastasis occurs when cancer spreads to other parts of the body. Some patients have asked whether scalp cooling increases the chance of metastases in the scalp. 

A study published in 2017 reviewed patients with breast cancer receiving chemotherapy while using scalp cooling for hair preservation and found there was no statistical difference in the incidence of scalp metastasis between patients using scalp cooling vs. no scalp cooling. The study concluded that “based on this extensive review and meta-analysis, scalp cooling is highly unlikely to increase the incidence of scalp metastases in patients with early-stage breast cancer receiving adjuvant chemotherapy.” 

For more information about scalp metastases, CLICK HERE.

RESEARCH OVERVIEW – QUALITY OF LIFE

Minimizing hair loss helps patients to preserve personal identity and self-esteem and appear normal as opposed to sick. Protecting privacy and gaining the ability to choose whether to disclose a cancer diagnosis is significant to many patients. Additionally, scalp cooling patients gain a much-needed sense of control in an otherwise overwhelming experience.

For more information about quality of life related to scalp cooling, CLICK HERE.

For more information, download the DigniCap Summary of Clinical Evidence HERE.