Safety and Efficacy of an Oral Nutraceutical Supplement Gummy and Peptide Serum in Promoting Hair Growth: Initial Results of A Randomized Placebo Controlled Trial with an Open Label Extension

Abstract

Background Female pattern hair loss (FPHL) has a significant psychosocial impact, yet limited FDA approved treatments, leading many to seek nutraceutical alternatives, which lack clinical evidence. This study evaluates a combined oral and topical regimen to promote hair growth and density. 

Methods Eighty-five females aged 28-65 with self-perceived hair thinning and FPHL will receive active or placebo proprietary nutraceutical supplement gummy and peptide serum for three months, followed by a six month open label phase. Outcomes include phototrichogram analysis, participant assessments, SOCAi™ analysis, and investigator assessments. Safety is assessed via adverse events (AEs) and laboratory assessments.  

Results Interim data for forty-eight enrolled females with Ludwig I or II FPHL was  analyzed (Table 1):  

• Higher mean change in hair count in the active vs. placebo group after three months.


• In the active group, 82.6% of patients showed improvement in WAASQ scores, with mean improvement of 26.7% at three months and continued improvement at six months.


• IAAGA was significantly higher in the active group compared to placebo after three months (Figure 1).


• The treatment group showed a 312% relative improvement compared to placebo and 26.4% improvement compared to the crossover group per SOCAi™ analysis (Figures 2 & 3). 


• Meaningful change is trackable in just 90 days with SOCAi™ (Figure 4).


• PGIS scores improved in 62.5% of active participants at three months (Figure 5).

No clinically significant laboratory changes. Seven AEs were reported, majority were mild to moderately severe and deemed unrelated to treatment.

Conclusion Initial data suggests that this proprietary nutraceutical supplement gummy and peptide serum appears to be safe and effective in the treatment of FPHL, a condition where treatment options remain limited despite high prevalence and significant patient burden.