Follicum has announced that the clinical Phase IIa study with a cream-like formulation of FOL-005 will re-start, following a pause due to the Covid-19 pandemic.
To increase the recruitment rate, a third study centre has been contracted. The study comprises approximately 200 male patients with hair loss who are treated daily for four months with the newly developed formulation of FOL-005 or placebo. The study is being conducted at the Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin, proDERM in Hamburg, and the new center, CentroDerm in Wuppertal.
“It is very gratifying that we now can re-start the study and continue the recruitment of patients. As we re-start, we have contracted another experienced and reputable study centre to increase the recruitment rate. The aim of the current study is to confirm the interesting results that we have seen in previous studies, this time in a larger patient group and with the cream-like formulation that we developed and tested during the past year. Hair loss affects a very large number of people, both women and men. Nonetheless, there are few effective and safe treatments available. We hope that FOL-005 will prove to be a breakthrough,” says Jan Alenfall, CEO, Follicum.
Results communicated in spring 2021
In two previous clinical studies, FOL-005 administered as an intradermal injection has been shown to be an effective and safe treatment for stimulation of hair growth. The current Phase II study aims to investigate the safety, efficacy and response of the drug candidate FOL-005 in a topical formulation.
The patients themselves will apply a cream with three different strengths of FOL-005 or placebo in the scalp, once daily in the evening. The study is expected to be completed and the results communicated in spring 2021.