The Korean Ministry of Food and Drug Safety recently approved a Phase IIb clinical trial for Dangook University Hospital’s Dermatology Department to study the efficacy of botulinum toxin Nabota for the treatment of hair loss on 48 male study participants. 

Sponsored by Daewoong Pharmaceutical, the Korean company has been collaborating with clinical investigator Park Byung-cheol, professor of dermatology at Dangook University Hospital.

Park Byung-Cheol’s Results from Last Study

Korean Biomedical Review reports that Park Byung-cheol previously conducted a clinical trial to tap the possibility of Nabota’s efficacy to treat hair loss. The Korean investigator injected 30U of Nabota into the dermis-fat border circling his patients’ hair follicles. The study participants received 6 injections each month for 24 weeks. At the end of the study, each patient had received 1800U of Nabota for the investigator to observe the hair growth effect. Results revealed that seven hairs grew per 1 cm(2) of scalp six months after treatment.

The Study

Sponsor Daewoong Pharmaceutical and clinical investigator partner Dangook University Hospital seek to understand in the upcoming Phase IIb study if Nabota results could be statistically significant via a larger study and hence gain attention with the biopharmaceutical industry.

What is Nabota Indicated for?

Developed in-house by Daewoong, botulinum toxin Nabota was recently approved by the FDA for skin wrinkle treatments. In Korea it was approved the regulatory authority there for wrinkles, improvement of wrinkles in eyes, and indication of upper limb muscle stiffness after stroke.  Apparently the sale of Nabota in America is conducted via a local partner called Evolus: a firm that specializes in the sale of cosmetic indications. Its parent company—Alphaeon, was founded by more than 200 opinion leaders from the American Society of Cosmetic Art reports, according to one report.

Dangook University Hospital Profile

Dangook University Hospital (DKUH) was established in 1994 to improve regional health through the advanced level of medical education, research and medical care. The academic medical center employs 1,300 medical and hospital staff and strive for a “patient oriented culture.” DKUH is the largest general hospital in  the Chung Nam Province, with 900 patient beds and 33 specialty clinics including Internal Medicine, Surgery, Ophthalmology, ENT, PM and R, Diagnostic Radiology and many others. DKUH is active in clinical research including clinical trials.

Daewoong Pharmaceutical

Daewoong Pharmaceutical was founded in 1945 and is a mid-market pharma with global aspirations. It counts annual turnover just under $1 billion as of 2019 and 1,487 employees. It includes seven affiliate companies. Its portfolio includes 15 “blockbuster” products. Its pipeline includes new chemical entities and biologics and regenerative medicine.

Lead Research/Investigator

Park Byung-cheol, Professor of Dermatology at Dangook University Hospital.

Call to Action: Interested in the results of this study? TrialSite News will monitor and report on results. TrialSite Network includes access to Dr. Park Byung-cheol.

Source: Korea Biomedical Review

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