Intradermal injections of a hair growth factor formulation for enhancement of human hair regrowth – safety and efficacy evaluation in a first-in-man pilot clinical study

ABSTRACT
Background: Research has shown the efficacy of hair growth factors in hair regrowth. We describe the
intradermal injections of a recombinant, bioengineered hair formulation, containing growth factors, into
the scalp skin, for enhancement of hair regrowth and evaluate its efficacy. 
Objectives: The objective of
this study was to assess the efficacy and safety of the hair growth factor formulation in reducing hair loss
and enhancing hair growth. 

Materialnd methods as: This was an open-label, prospective, single-arm
interventional pilot study in which 1000 patients were given intradermal injections of a hair formulation
into the scalp skin. The formulation contains vascular endothelial growth factor, basic fibroblast growth
factor, insulin-like growth factor, keratinocyte growth factor, thymosin β4, and copper tripeptide-1
suspended in a sterile injectable vehicle. Intradermal injections of this hair formulation were injected
into the scalp once every 3 weeks for a total of eight such sessions. Hair pull test was performed before
every session. Videomicroscopic and global images were taken at baseline, fourth session, eighth
session, and 2 months after the completion of the eight sessions. Relevant safety assessments through

physical examination, questionnaires, and appropriate laboratory examination were conducted through-
out the study. 

Results: Significant reduction in hair fall was seen in 83% of the patients on hair pull test.
Videomicroscopic image evaluation showed that most patients had a decrease in the number of vellus
hairs, increase in number of terminal hairs, and increase in shaft diameter. Seventy-five percent of the
patients believed that the hair injections were aiding the treatment of their hair loss, and it was also
beneficial in post-hair transplant patients. At 1 year, a statistically significant increase in total hair count
(P = 0.002) continued to be seen. Treatment was well tolerated. 

Conclusions: Intradermal injections of
this hair formulation may be a promising option for treating male as well as female patterns of hair loss.

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