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.
Level 4 - case-series / case-control
Prospective, open-label, single-arm interventional study without a control group.
PubMed 29482481 · doi:10.1080/14764172.2018.1439965
What was done
An open-label, prospective, single-arm interventional pilot study evaluated the safety and efficacy of intradermal scalp injections of a bioengineered growth factor formulation in 1,000 patients with hair loss. The formulation contained vascular endothelial growth factor, basic fibroblast growth factor, insulin-like growth factor, keratinocyte growth factor, thymosin β4, and copper tripeptide-1. Participants received injections every 3 weeks for 8 sessions. Outcomes included hair pull tests before each session, videomicroscopy, global photography (baseline, 4th and 8th sessions, and 2 months post-treatment), participant questionnaires, safety labs, and 1-year hair count assessment.
What was found
Hair pull testing showed reduced hair fall in 83% of patients. Videomicroscopy showed decreased vellus hair counts, increased terminal hair counts, and increased hair shaft diameter in most patients. Overall, 75% of patients reported perceived treatment benefit. At 1 year, total hair count showed a statistically significant increase (P = 0.002), though exact numerical baseline and endpoint values were not provided in the abstract. Treatment was reported to be well tolerated.
Why it matters
This study provides uncontrolled clinical data on a multi-target growth factor injectable formulation for androgenetic or pattern hair loss.
Limits
The study was a single-arm, open-label trial with no placebo or active control group. The abstract omits exact numerical values for hair counts, shaft diameters, baseline demographic characteristics, and specific safety/adverse event rates.
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