Daewoong Pharmaceutical said it would conduct a clinical trial on botulinum toxin Nabota for the treatment of hair loss.
The Ministry of Food and Drug Safety on Monday approved the phase-2b study on Nabota in patients with male pattern baldness.
|Daewoong Pharmaceutical’s botulinum toxin Nabota|
Park Byung-cheol, a professor at the Dermatology Department of Dangook University Hospital, plans to evaluate the efficacy and safety of Nabota in 48 patients with male pattern baldness.
Earlier, Park conducted a sponsor-investigator trial to tap the possibility of Nabota’s efficacy to treat hair loss. He injected 30U of Nabota into the dermis-fat border around hair follicles of the patients. The patients received six injections, once a month for 24 weeks. Park injected a total of 180U of Nabota per patient to observe the hair growth effect.
The result showed that seven hairs grew per 1㎠ of scalp six months after the Nabota treatment.
There was only one clinical trial that studied the relationship between the botulinum toxin and hair loss. Although this study had a clinical evaluation of the efficacy, it did not confirm how the mechanism worked.
The upcoming phase-2b study on Nabota might show statistically significant data, drawing attention in the pharmaceutical industry.
Nabota is indicated for frown lines, upper limb muscle stiffness after stroke, eye wrinkles, and eyelid twitches. Daewoong Pharmaceutical is working on trials to widen Nabota’s indication into facial paralysis and dysfunctional tear syndrome.
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