An Open Label Clinical Trial of a Novel 3 Product Skin Brightening Regimen
Skin Brightening System is an effective skin care regimen specifically
formulated to restore skin brightness and radiance as it lessens the appearance
of dark spots and fine lines. Developed by a board-certified dermatologist, this
3-step system protects skin from free radical damage and pollution that cause
excess pigment, while blocking the formation of the skin pigment melanin.
Clinically tested to deliver proven results with a combination of concentrated,
medical grade actives and natural ingredients.
Hyperpigmentation presents a common aesthetic concern among patients,
posing a significant treatment challenge for skincare specialists. For over five
decades, hydroquinone (HQ) stood as the gold standard in hyperpigmentation
treatment. However, its use has faced stringent regulations in numerous
countries due to safety concerns. Consequently, clinicians have sought safer
and more effective alternatives for skin brightening.
In the late 20th century, there was a surge in the popularity of hydroquinone
combined with other compounds in the United States. This combination,
often referred to as the “Kligman formula,” typically comprised hydroquinone
alongside a corticosteroid to mitigate inflammation and tretinoin to counteract
corticosteroid-associated atrophy, remove pigment stored in keratinocytes, and
enhance hydroquinone penetration. Despite its initial popularity, the safety
profile of hydroquinone, characterized by risks such as exogenous ochronosis,
permanent depigmentation following prolonged use, and the generation of
reactive oxygen species (ROS) causing oxidative damage, led to its ban in the
European Union (24th Directive 2000/6/EC).
The apprehension regarding hydroquinone’s safety has extended beyond
Europe, with an increasing number of consumers and skincare specialists in
the United States and Asia expressing concerns. Consequently, hydroquinone
has gradually fallen out of favor, creating a demand for alternative, skin-friendly,
and risk-free skin brightening solutions conducive to long-term use.
This study aims to evaluate the efficacy of a hydroquinone-free, three-step
at-home regimen for skincare. The regimen comprises:
The primary objective is to assess the efficacy and tolerance of this three-step
hydroquinone-free at-home medical-grade skincare regimen, supplemented
with the patient’s own SPF product. The study aims to ascertain its effectiveness
in brightening skin tone, improving texture, and reducing the visibility of dark
spots and fine lines.
To assess the efficacy and tolerance of a 3-step hydroquinone-free at-home
medical grade skincare regimen plus patient’s own SPF product to brighten
skin tone, smooth texture and lessen the appearance of dark spots and fine
lines.
Sixteen testers, ages 34 to 62, were assessed by a board- certified dermatologist
for a total of 12 weeks. Physical exam and digital photography were used to
document each subject’s skin at baseline and then at 2, 4, 6 and 12 weeks.
Photos were taken of full face, right and left face with visible and cross-polarized
light using the Reveal photo station (Canfield Imaging Systems, Fairfield, NJ).
A cleanser incorporating 2% salicylic acid, beta hydroxy acid, combined with
1% virgin coconut oil at pH 4.5.
A serum featuring LipochromanTM, a proven anti- pollution and strongest free
radical scavenger on T-Bar assay combined with Vitamin E (alpha tocopherol)
and linoleic and linolenic acids, and glycolipids for barrier replacement.
A cream featuring an anhydrous formulation of 20% L-ascorbic acid in an
airless dispenser to optimize stability of active.
Also noteworthy is that the regimen omits specific known skin sensitizers
including hydroquinone, retinoids, parabens, dyes, and artificial fragrance.
For the first two weeks, the testers were instructed to use the cleanser and
serum every morning, followed by their own SPF 30 or higher and at night
to use the cleanser, serum and Vitamin C moisturizer. After two weeks, they
were evaluated for any redness or irritation from the regimen. Those who did
not have any signs or symptoms of irritation (secondary to the 20% L-ascorbic
acid) could go on to use the cream twice daily. One of the 16 testers experienced
significant redness and she was directed to continue to use the Vitamin C
cream only in the evenings for the duration of the study.
CLEANSER: ACCELERATION OF EPIDERMAL TURNOVER AND
DESQUAMATION TO LESSEN MELANIN STORES
Salicylic Acid (SA) is a beta-hydroxy acid found in willow bark and sweet
birch. SA functions as a desquamating agent that penetrates and dissolves the
intercellular matrix of the stratum corneum. It’s known that ingredients that
accelerate the turnover of epidermal layers and/or disperse melanin pigment
can result in skin lightening. Exfoliating agents stimulate the removal of
pigmented upper layer keratinocytes to lighten skin [2]. Coconut oil is both a
hydrating agent and an antioxidant to help to lighten and brighten skin surface
by increasing skin luminosity through hydration and brighten as an antioxidant
SERUM: LINOLENIC AND LINOLEIC ACIDS, VITAMIN E,
LIPOCHROMANTM LIGHTEN DARK SPOTS TO BRIGHTEN SKIN
Linolenic and Linoleic Acids: Unsaturated fatty acids including linoleic acid and
linolenic acid have been reported to suppress melanogenesis and tyrosinase
activity. Linoleic acid reduces the activity of tyrosinase in melanocytes,
while mRNA levels remain unchanged [3]. Linoleic acid also influences skin
pigmentation by stimulating epidermal turnover and increasing desquamation
of melanin pigment from the epidermis. Studies completed to assess the skin
lightening capabilities of unsaturated fatty acids, linoleic acid or linoleic acid on
UV induced hyperpigmentation showed an efficient lightening effect [4].
Alpha Tocopherol (Vitamin E): Vitamin E is a lipophilic antioxidant known
to inhibit the oxidative attack of free and membrane bound unsaturated fatty
acid and to interfere with the lipid peroxidation of melanocyte membranes.
It also acts to scavenge free radicals including superoxide anions, hydroxyl
radicals and singlet molecular oxygen. It can also act as a humectant and is able
to inhibit tyrosinase in the formation of melanin [5].
LipochromanTM: LipochromanTM is a synthetic antioxidant shown to rate as
the most effective antioxidant on the T-Bar assay for antioxidant strength. The
use of antioxidants for skin brightening dates back to work done with Vitamin
C in the 1980s (see below). A study published in 2015 showed that pollution
associated with people living near an interstate highway is linked to 20% or
more age spots than peer age-matched individuals [6].
THE CREAM: ANHYDROUS VITAMIN C INTERFERES WITH
MELANIN AND FIRMS AND SMOOTHES SKIN APPEARANCE
L-ascorbic acid (vitamin C) is a water soluble vitamin and the most plentiful
antioxidant in human skin. It interferes with melanin synthesis by reducing
oxidized dopaquinone, and thus blocking the action of tyrosinase. L-ascorbic
acid is a free radical/ROS scavenger that neutralizes free radicals in skin [7].
L-ascorbic acid is highly unstable and is rapidly oxidized and decomposed in
aqueous solutions.
L-ascorbic acid formulations in the marketplace have as a major ingredient
water which may compromise the stability and efficacy of the formulation
[8]. The anhydrous formulation of 20% L-ascorbic acid has no pH since pH
is a measure of H ions and without water there is no pH. Also, lack of water
maximizes the stability of the L-ascorbic acid and the airless packaging also
lowers the risk of oxidation of the formulation. In the present study we use a
unique formulation of L-ascorbic acid that is anhydrous (no pH) and infused
with citrus essential oil to boost patient compliance and antioxidant benefits.
Sixteen participants, aged between 34 and 62, were recruited for a 12-week clinical
assessment conducted by a board-certified dermatologist. Baseline evaluations
of each participant’s skin were performed through physical examination and
digital photography. Subsequent assessments were conducted at 2, 4, 6, and
12 weeks using the Reveal photo station (Canfield Imaging Systems, Fairfield,
NJ), capturing images of the full face, right and left sides with both visible and
cross-polarized light.
The skincare regimen utilized in this study consisted of three products:
During the initial two-week period, participants were instructed to apply the
cleanser and serum each morning, followed by their preferred SPF 30 or higher
sunscreen. In the evening, they were directed to use the cleanser, serum, and
Vitamin C moisturizer. After this initial phase, participants were assessed for
any signs of redness or irritation attributed to the regimen. Those who exhibited
no adverse reactions, particularly to the 20% L-ascorbic acid, were permitted to
incorporate the cream into their routine twice daily.
The skincare regimen was well tolerated by all participants, with high
compliance observed throughout the study period. Notably, 87% of participants
demonstrated improvement in the reduction of dark spots (Figure 1). Significant
enhancements were also observed in skin radiance and overall lightening, with
a 100% improvement rate (Figure 2). By week 12, all participants exhibited
improved skin smoothness, indicating a 100% success rate in this aspect (Figure
3). Additionally, 93% of participants experienced improvements in the appearance
of fine lines and wrinkles by the end of the 12-week period (Figure 4).
One participant experienced significant redness during the initial phase and
was advised to limit the use of the Vitamin C cream to evening applications for
the duration of the study.
Since we are referenceing specific B&A images in the results, I think we should
make the image headings referenced (example: “figure 1”) larger and easier to locate.
Hyperpigmentation remains a significant concern in dermatology, prompting
the search for alternatives to hydroquinone (HQ) due to its regulatory
constraints and safety concerns. This study aimed to evaluate the efficacy of a
hydroquinone-free, three-step at-home skincare regimen.
The results show promising improvements in various aspects of skin health
and appearance. High compliance among participants indicates the regimen’s
feasibility and acceptability in real-world settings.
Many participants reported significant improvements, including the reduction of dark spots, enhanced skin radiance, lightening, improved skin smoothness, and reduced appearance of fine lines and wrinkles.
The reduction in dark spots confirms the regimen’s effectiveness in treating
hyperpigmentation. Enhanced skin radiance and overall lightening suggest a
comprehensive brightening effect. Improved skin smoothness aligns with the
regimen’s exfoliating and moisturizing components, promoting skin renewal
and hydration. The reduction in fine lines and wrinkles indicates potential antiaging
benefits, likely from the antioxidants and Vitamin C in the cream.
Despite these positive outcomes, it is important to note adverse events, such
as significant redness experienced by one participant, highlighting the need for
individualized skincare.
In conclusion, this study demonstrates the efficacy and tolerability of a
hydroquinone-free, three-step at-home skincare regimen in improving skin
health and appearance.
BASELINE
AFTER 6 WEEKS
This 52 year old man grew up in Florida and had a 15 year history of dark patches of temples and cheeks. He used SPF 30 or more regularly and had been treated with liquid nitrogen and 5-Fluorouracil 5% cream in the year prior to starting Skin Brightening System. Improvement in dark spots, radiance and skin smoothness was noted after 6 weeks of use of the regimen.
BASELINE
AFTER 4 WEEKS
This 34 year old woman complained of loss of luminosity and radiance. Improvement
in overall radiance, tone and smoothness was noted after 6 weeks of use of the regimen. She also had improvement in forehead lines not seen in this photo.
BASELINE
AFTER 6 WEEKS
This 58 year old woman complained of overall skin roughness and blotchy and spotted complexion. Overall brightening, increased smoothness, lessening of dark spots and lines and creases were noted after 6 weeks of use of the regimen.
BASELINE
AFTER 4 WEEKS
This 62 year old woman had a long history of UV overexposure and cigarette smoking. She complained of lines, wrinkles, rough texture, loss of luminosity and dark “age” spots. Improvement in lines and wrinkles, dark spots, radiance, and overall smoothness was noted after 6 weeks of use of the regimen.
