Pro-Niacin White Paper
Effect of Pro-Niacin™ on
Retinoic Acid (RA) Therapy for Facial
Sun Damage
Summary of Study Findings
(Published; Experimental Dermatology October 2007)
Premise of Study
Retinoic
Acid/Vitamin A
has been used to treat sun damage and acne for many years.
Studies report that Retinoic Acid
(RA) can produce smoother, less wrinkled, less pigmented skin
because it improves cell turnover, lightens pigment, increases
collagen production and reduces cell matrix degradation.
While
RA provides multiple benefits for sun
damage, it also can cause side effects such as skin irritation,
dryness, peeling, erythema and a burning sensation on the skin.
RA is known to impair skin
barrier function, which may contribute to these associated side
effects.
Pro-Niacin™,
also known as
Myristyl Nicotinate – a
patented lipophilic derivative of Niacin, has been shown to increase
stratum corneum and epidermal thickness and enhance skin barrier
function. This study
examined the combined use of
Pro-Niacin™ with
Retinoic Acid on skin barrier
integrity, tolerability and efficacy of RA
therapy.
Study
Parameters
Ø
Randomized, Double Blind, Placebo-Controlled Trial (RDBPCT) conducted
by CRO (contract research organization).
Ø
4 Week Pre-Treat with 12 Week Therapy Duration, with observations at
baseline, 2, 4, 8 and 12 weeks.
Ø
Female Subjects ages 30-60 with mild to moderate sun damage (1-4
Fitzpatrick Skin Class, 86% Caucasian)
Ø
3 Groups (20 subjects each)
ØSubjects applied
Pro-Niacin™ moisturizer twice
daily after cleansing and RA once
daily in the evening
Ø
Evaluated: 1 - Markers of skin barrier function – punch biopsies, TEWL
(trans-epidermal water loss) and image scan; 2- Clinical and sensory
irritation – clinical grading and patient self-assessment; 3- Efficacy
of RA therapy – clinical grading and
patient self-assessment.
Clinical
Findings with Statistical Significance
Ø
Retinoic Acid therapy
alone resulted in
25% thinning of stratum
corneum and 45% increase
in TEWL
(Trans-Epidermal Water Loss measures barrier integrity.
The stronger the skin barrier, the more difficult for moisture
to escape and thus TEWL is lower).
Ø
Pro-Niacin™
decreases stratum corneum
thinning associated with RA therapy.
Ø
Pro-Niacin™
reduces the increase in TEWL
associated with
RA therapy.
Ø
Pro-Niacin™
improves the tolerability of
RA therapy.
Ø
Pro-Niacin™
does not interfere, and in
some cases improves the
efficacy of RA therapy.
Conclusions
Ø
Pro-Niacin™
reduces the side effects (stinging, tingling, burning) of
Retinoic Acid therapy associated with
barrier impairment. The
greatest improvements in skin barrier integrity and tolerability of
treatment were seen in subjects that pre-treated with
Pro-Niacin™ one month prior to initiating concurrent
RA therapy and continued
5% Pro-Niacin™ use.
Ø
This study proves with statistical significance that PRIOR and
CONCURRENT use of Pro-Niacin™
improves the tolerability of RA therapy
without interfering with efficacy.
