Validation Study to Evaluate the Efficacy and Safety of a Hair Growth Gummy Nutraceutical Supplement in Women

Abstract

Introduction Hair loss and thinning impact millions of women worldwide and stem from
the interaction between biological stressors, including inflammation, hormonal
imbalances, and nutritional deficiencies. These factors disrupt normal follicular activity,
resulting in reduced strand density and overall scalp coverage. Non-scarring forms of
alopecia, including alopecia areata (AA) and androgenetic alopecia (AGA), cause hair
shedding without permanent follicle damage, while scarring forms like central centrifugal
cicatricial alopecia (CCCA) can lead to irreversible follicular loss. Although nutraceutical
supplements targeting alopecia are available, most are formulated as capsules, creating
a barrier for individuals who have difficulty swallowing medications. This highlights a
need for more patient-centric delivery options. This study evaluates the efficacy and
safety of Xtressé™, a novel dermatologist-developed nutraceutical gummy formulated
to support follicular health and proactively combat hair loss.
Procedure Eligible participants were women between the ages of 18 and 65 with self-
perceived hair thinning or female pattern hair loss (FPHL). Enrollment required the use
of contraception throughout the study period and no alterations to medication or
supplement routines within three months before participation. Over a four-month
treatment window, patients were instructed to take two gummies daily with a meal,
maintaining a consistent time of consumption. Changes in hair follicle and density were
tracked using SOCAi Vision™ intelligence technology, which offers global scalp
coverage with heatmap-style analysis, alongside Canfield HairMetrix® analytic software,
which provides microscopic analysis of a single, fixed scalp area. Patients returned for
follow-up assessments 4-9 weeks following baseline.
Results: This pilot study has enrolled over 50 women, with longitudinal data available
from 11 patients with AGA who completed multiple visits. Canfield HairMetrix®
assessments have demonstrated that 9 out of 11 (81.8%) individuals have shown
increases in total and terminal hair counts. Responders have experienced a mean
change of + 13.69 for hairs/cm² with +6.78 terminal hairs/cm² and +253.92 µm/cm² in
overall sum of hair shaft widths. Findings from SOCAi Vision™ indicate improvement in
9 out of 10 participants (90%). Among this group, visible hair loss decreased from
22.2% to 17.0%, representing approximately a 23% relative improvement in global hair
thinning. Concordance between the two software was approximately 70%. This
emphasizes the value of capturing broader scalp-level changes in determining treatment-related changes. The gummy format was well tolerated, with adherence
driven by its convenience and flavor.
Conclusion Xtressé™ shows early clinical promise as a well-tolerated nutraceutical for
promoting hair restoration for individuals struggling with hair loss and thinning. Findings
from two analytic platforms reveal a pattern of improvement in both hair density and
fiber integrity, indicating renewed follicular activity among women with FPHL or
perceived thinning. These early changes suggest that this nutraceutical may help shift
follicles toward more active growth states. Notably, its gummy formulation offers a user-
friendly alternative to conventional capsules, offering a non-invasive intervention for
enhancing hair aesthetics.