Kintor Announces Enrollment for New Trial and Update of Previous Phase 3 for Androgenic Alopecia

Kintor Pharmaceutical has recently announced the enrollment of its first participant in its “Pivotal Clinical Trial”. This is a Phase 2/3 trial in which men with androgenic alopecia will be treated with either vehicle control, 0.5%,  or 1% topical for 24 weeks. The trial will be conducted in China, with 222 patients enrolled in each group (666 patients total). 

The press release also announced an update for its 52-week Phase 3 trial, “Long-term Safety Clinical Trial”, which completed enrollment in July 2023. Participants were treated with 0.5% tincture twice daily.

Trial Results

• No serious adverse events were reported, the most common being mild itching at the application site.
• After 12, 24, 36, and 52 weeks of treatment, target area hair count (TAHC) and target area non-vellus hair width (TAHW) increased from the baseline:
  • TAHC increased by 9.5%, 13%, 11.4%, and 9.7%, respectively.
  • TAHW increased by 12.1%, 18.6%, 15.7%, and 10%, respectively (a statistically significant increase from the baseline).
  • At week 24, 60.2% of participants had a ≥10 hairs/cm² change in TAHC from baseline, 28.9% had a ≥20 hairs/cm2 change, and 18% had a ≥30 hairs/cm2 change.
  • At Week 52, 48.4% of participants had a ≥10 hairs/cm² change in TAHC from baseline, 20.4% had a ≥20 hairs/cm2 change, and 11.8% had a ≥30 hairs/cm2 change.
• Hair growth was assessed subjectively by investigators:
  • 60.9%, 69.5%, 64%, and 54% of participants showed improved hair growth from the baseline at 12, 24, 36, and 52 weeks respectively.

Reflections

While the results appear promising, there are several potential issues to consider:

• The trial had no placebo or comparator.
• The TAHC and TAHW improvements peaked at 24 weeks and then declined, raising questions about long-term efficacy.
• The percentage of patients achieving  ≥10, ≥20, and ≥30 hairs/cm² improvements also decreased from 24 to 52 weeks.
• It is difficult to determine the clinical significance of the percentage increases without knowing the baseline data.
  • Regardless, the percentage increases of TAHC are not that high and not statistically significant, indicating that it might not improve long-term hair growth outcomes in a clinically significant way.

Let us know what you think about these results below.