Effects of Oral Administration of Ellagic Acid-rich Pomegranate Extract on Ultraviolet-induced Pigmentation in the Human Skin


J Nutr Sci Vitaminol. 2006;52:383–88.
Longer exposure to UV light could lead to skin inflammation, DNA mutations and much more. More commonly, UVA and UVB radiation have long been suspected of producing harmful effects on skin, such as hyperpigmentation.

Pomegranate (Punica granatum) has been known to possess strong antioxidant and anti-atherogenic effects in humans. Ellagic acid, a naturally occurring polyphenol found in several natural sources like pomegranate, has been found to inhibit UV-induced pigmentation of skin both in animal and human.

Objective:

To evaluate the protective and ameliorative effects ellagic acid-rich pomegranate extract on UV irradiation-induced pigmentation of human skin.


Study Design:

  • Thirty nine healthy female volunteers (age: 20–40 years) were included in this double-blind, placebo-controlled study
  • All the subjects were randomly assigned (n=13) to receive high-dose pomegranate extract (200 mg/day ellagic acid, H), low-dose pomegranate extract (100 mg/day ellagic acid, L) or placebo (P) for 4 weeks
  • Each participant received 1.5 minimum erythema dose (MED) of UV irradiation on the inside of the upper left arm before consuming the test product
  • Evaluation parameters like luminance, melanin and erythema values were determined at baseline, week 1, 2, 3 and 4
  • Additionally, questionnaires regarding the state of the skin before and after the study period were evaluated

Results and Discussion:

  • A statistically significant inhibition against decreasing values of luminance was observed in both group L (at week 1, 2; p<0.01, and week 4; p<0.05) and group H (at week 2 and 3; p<0.05) (Fig. 1)
  • Similarly, a tendency towards inhibiting the increase in melanin and erythema values was seen in group L at week 1
  • Data from questionnaires revealed that more number of subjects from group L and H reported improvement in “brightness of the face” and “stains and freckles” than group

Conclusion:

In conclusion, ellagic acid-rich pomegranate extract exhibits protective and ameliorative effects against UV irradiation in human skin when ingested orally.

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An Open-Label Single-Arm, Monocentric Study Assessing the Efficacy and Safety of Natural Pterostilbene (Pterocarpus marsupium) for Skin Brightening and Antiaging Effects


Clinical, Cosmetic and Investigational Dermatology 2020:13
A new clinical study published by Sabinsa, in Clinical, Cosmetic and Investigational Dermatology, demonstrates the anti -ageing and skin brightening effect of PteroWhite® (natural pterostilbene) in human volunteers. The study was conducted as an open-label, single-arm, monocentric efficacy study in 38 healthy volunteers who applied a cream containing 0.4% pterostilbene for a period of 8 weeks . The dermatological assessment, together with instrumental and image analysis suggests that pterostilbene effectively improves skin brightness, elasticity, reduces the appearance of fine lines, wrinkles, and improves skin texture as compared to baseline in the subjects studied.

A positive change was observed at all time points in skin hydration and elasticity in both male and female subjects with regular usage of the PteroWhite® cream. Significant improvement was observed in under-eye fine lines at all-time points and in wrinkles, frown lines, and crow’s feet area at the end of the study. Pterostilbene was able to improve the skin luminosity with continuous application. All the study subjects agreed that the test product makes their skin moisturized, brighter, younger, firmer, and make their skin look even toned. Further, no product-related skin irritation, intolerance, or adverse event recorded during the study. The study concluded that application of pterostilbene cream twice daily for 8 weeks was safe, and improved skin texture tone, and helps in keeping skin moisturized, supple and young. The study can be accessed at https://doi.org/10.2147/CCID.S238358

 


Objective:

Both intrinsic and environmental factors play a role in premature ageing of the skin. Natural extracts have been extensively used to reduce the signs of ageing in recent years. Pterostilbene is a natural analog of resveratrol with therapeutic properties against numerous diseases mainly due to its ability to reduce reactive oxygen species.


Study Design:

  • This was an open-label, single-arm, monocentric efficacy study
  • It was conducted for 8 weeks for each subject and included a total number of 4 visits, ie, Day1(baseline visit),Visit 2: Week2 (W2), Visit 3:Week4 (W4), Visit 4:Week8 (W8)
  • The objective of the study was to assess the efficacy of Natural Pterostilbene for skin brightening benefit as well as improvement in skin hydration in comparison to baseline, to evaluate the efficacy in imparting anti-aging attributes such as the reduction in fine lines, wrinkles & elasticity in comparison to baseline and Skin tolerance monitoring for product safety
  • Evaluation for the brightening benefit was carried out for 4 weeks and anti-aging attributes for 8 weeks by dermatological assessment, non-invasive instrument assessment, and imaging assessment
  • The upper inner arm (VB Volar Biceps) of the subjects was used as a control for the brightening assessments
  • Subjects were provided with the test products to apply one fingertip unit uniformly on complete face twice daily throughout the study (8 weeks)
  • They were instructed not to use additional sunscreen
  • There was no change in the subject’s other skincare regimen for the entire duration of the study which has no direct or indirect effect on our study outcome
  • The subjects were to carry their allotted test products to the study center on each visit

Results and Discussion:

  • Natural pterostilbene showed significant inhibition of melanogenesis in vitro
  • Pterostilbene cream (0.4%) was highly effective in reducing markers of aging and induces even skin tone
  • The product was effective in reducing wrinkles and fine lines, improved skin hydration elasticity and showed no adverse effects

Conclusion:

Our results suggest that natural pterostilbene is a safe and effective ingredient for use in cosmetic preparation to reduce the markers of skin ageing and brighten the skin tone.

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A Randomized Study to Determine the Sun Protection Factor of Natural Pterostilbene from Pterocarpus marsupium


Cosmetics 2020, 7(1), 16;
In a second clinical study, on natural pterostilbene, published in the Journal “Cosmetics”, Sabinsa corporation demonstrated the effect of PteroWhite® as a natural SPF ingredient. With the current status of chemical sunscreens, and the concerns about their systemic absorption and safety, this study has demonstrated PteroWhite® as a safe alternative. A cream formulation containing 4% of PteroWhite® was evaluated in 12 healthy volunteers as per the ISO 24444:2010 regulations showed an in vivo SPF value of 6.2 ±1.30.

The cream was found to be safe and nonirritant in a repeated patch test conducted in 25 healthy individuals, prior to the SPF study. The cream showed an SPF of 8.84 ±0.01, in vitro, while PteroWhite® as an ingredient had an SPF value of 21.73 ±0.06. Further, the study demonstrated the potent antioxidant effects of PteroWhite® in the in various in vitro and cellular test systems. The study concluded that PteroWhite® could be used as a safe ingredient in topical sun-protective formulations. Further details of the study could be accessed at https://doi.org/10.3390/cosmetics7010016

 


Objective:

The purpose of this study was to determine in-vitro and in vivo SPF of natural 90% pterostilbene extracted from the dried heartwood of Pterocarpus marsupium (Indian Kino). The SPF of purified pterostilbene and a formulation containing 0.4% pterostilbene was determined in vitro using a UV spectrophotometer.


Study Design:

  • Pterostilbene was extracted and purified from the Indian Kino tree (Pterocarpus marsupium)
  • Pterostilbene was dissolved in DMSO and diluted in 50% methanol for the assay
  • The oxygen radical absorption capacity assay (ORAC) for pterostilbene was assessed
  • Hydroxyl radical averting capacity was assessed using fluorescein (FL) as the fluorescent probe
  • ROS was estimated using dichloro-dihydro-fluorescein diacetate (DCFH-DA) dye
  • The SPF was determined In vitro by spectrophotometer, as described by Yang et al
  • The primary skin irritation study was conducted in a total of 25 healthy male and female subjects of all skin types (normal, dry, oily, and combination) in the age group of 18 to 55 years.
  • In the SPF determination study subjects in the age group 18–55 years (both ages inclusive) were included
  • The minimum dose that produces mild but definite erythema with a clearly defined border when evaluated at 24 h post-exposure was considered as MED
  • The efficacy of a sunscreen compound, expressed by the sun protection factor (SPF), is defined as the energy from UV required producing a minimal erythema dose (MED) on protected skin, divided by the UV energy required to produce a MED on unprotected skin
  • The arithmetic mean and standard deviation of the total observation was taken for both in vitro and in vivo SPF determination

Results and Discussion:

  • Antioxidant Activity of Pterostilbene
  • Reactive Oxygen Species Scavenging Capacity of Pterostilbene in vitro
  • In vitro SPF of Pterostilbene Cream Formulation of 0.4% Pterostilbene
  • In vivo Primary Skin Irritation Test of Pterostilbene Cream Formulation
  • In vivo Determination of Sun Protection Factor (SPF) of Pterostilbene Cream Formulation

Conclusion:

UV radiation causes skin damage and there is an urgent need to protect from its harmful effects. Natural ingredients usually have the potential to protect against the toxic effects of UV radiation. Natural pterostilbene has shown its potential as a safe and effective ingredient in topical formulations for sunscreens and UV protection. The product may be used in combination with other ingredients toboost the SPF value of sunscreen formulations. Further research is required in the development of new effcacious and safe plant-based natural ingredients and formulations which are effective in protecting skin from harmful radiations.

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A randomized, double-blind, placebo-controlled, comparative study: The safety and efficacy of 0.25% tetrahydrocurcumin (tumeric) cream as depigment agent against 4% hydroquinone cream


Household and Personal Care TODAY. 2010;44–46.
Agents that are used to ‘lighten’ or ‘whiten’ the skin are known as depigmenting agents/ whitening agents or skin tone lighteners. In cosmetics, such agents are found to be effective against localized hyperpigmentation, age spots and sun damage, and also help to impart a lighter skin tone. In medical practice, they are used in treating various pigmentation disorders.

Hydroquinone is one such agent that has been used as an active ingredient in skin tone lightening formulations for over 50 years. However, several adverse reactions, such as allergic and irritant contact dermatitis, leucoderma, and ochronosis, acneiform lesions and cancer (on prolonged use) have been reported that are associated with hydroquinone.

Hence, natural and safer alternatives like tetrahydrocurcumin are in great demand. This color-free compound is obtained from rhizomes of Curuma longa (turmeric). It is valued as a topical antioxidant and anti-inflammatory agent with potent free radical scavenging and lipid peroxidation inhibitory potential compared to vitamin E, kojic acid and vitamin C.


Objective:

To validate the safety and efficacy of 0.25% tetrahydrocurcumin (SabiWhite®) against 4% hydroquinone as a depigmenting agent.


Study Design:

  • In this randomized, double-blind, placebo-controlled study 50 healthy individuals were enrolled
  • The study consisted of two phases: A patch test phase (phase 1) and a clinical trial phase (phase 2)
  • During phase 1, volunteers randomly applied either 0.25% tetrahydrocurcumin cream or water at the back (scapular area) and readings were taken after 48 h and 72 h
  • During phase 2, test products were randomly applied on the right forearm of each individual twice daily by the investigator using a standard template for 4 weeks
  • Mexameter readings were taken at baseline, week 1, 2, 3, and 4, whereas clinical photographs were taken at baseline and on week 4
  • Adverse reactions, if any, to the test products administered were monitored and recorded at week 1, 2 3 and 4

Results and Discussion:

  • No adverse reaction or irritation was experienced by any individual during phase 1 patch test
  • In phase 2 study, mean mexameter readings showed that 0.25% tetrahydrocurcumin cream produced a significant whitening effect compared to the negative control groups with no incidence of adverse reactions
  • However, time-dependent increase in incidence of adverse reactions was observed with 4% hydroquinone cream, with 50% of the subjects experiencing mild-to-moderate reactions towards the end of week 4

Conclusion:

Hence, it was concluded that 0.25% tetrahydrocurcumin cream (SabiWhite®) is therefore a safe and effective alternative to 4% hydroquinone cream as a depigmenting agent.

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Multi-functional Botanicals for Topical Applications


Part 4.1.5, Harry’s Cosmeticology (9th Edition), 2015; p. 675–78.
Any damage or deterioration in the appearance or function of the skin due to chronic exposure to the sun (i.e. UV exposure) is termed as photo damage or photo aging, and is different from the natural aging process. Prolonged UV exposure of skin could lead to a sallow complexion with roughened surface texture, variable degrees of dyspigmentation, telengiectasias, wrinkling and skin laxity. Hence, process of photo aging could be delayed by avoiding prolonged sun exposure and/or applying proper sunscreens.

Tetrahydrocurcuminoids (THCs) are color-free compounds derived from the yellow curcuminoids extracted from rhizomes of Curcuma longa. They reported to be exhibiting potent antioxidant property combined with known COX-2 and tyrosinase inhibitory effects, thus making them useful natural ingredients in anti-aging and topical formulations designed to maintain general skin health and integrity.

Cosmoperine® is a cosmaceutical that augments the efficacy of topically co-administered compounds by making them more permeable.

 


Objective:

To compare the efficacy of topical cream containing THCs and Cosmoperine® with that of another cream containing only THCs on photo-damaged skin in healthy volunteers.


Study Design:

  • In this 3-month, prospective, randomized, double-blind, non-crossover, comparative clinical study, 20 participants (both male and female; age: 25–65 years) with mild-to-moderate photo-damaged skin were included
  • Subjects were randomized into 2 groups, one group receiving cream containing 0.5% THCs and 0.1% Cosmoperine® (X), and the other group receiving cream containing 0.5% THCs (Y)
  • A total of 5 visits to the clinic were scheduled, i.e. visit 0 (week 0), baseline visit/visit 1 (week 1) and follow-up visits (visit 2, 3 & 4 on week 3, 6 & 9, respectively), and the final visit at week 12
  • Efficacy assessment of both the creams was done on the basis of both patient’s and doctor’s global evaluations (i.e. overall appearance of the skin) and histopathological parameters like reduction in hyperkeratosis, collagen density and lymphocytic infiltration

Results and Discussion:

  • The patient’s and doctor’s global evaluation for overall appearance of the forearm skin (based on roughness, thickness, hyperpigmentation and wrinkling) at the baseline visit and the final visit revealed that cream X had shown better efficacy than cream Y (Fig. 1A and Fig. 1B, respectively)
  • Similarly, a significant reduction in hyperkeratosis, collagen density and lymphocyte infiltration was seen in the group that applied cream X compared to cream Y

Conclusion:

Overall, it was concluded that cosmoperine® in the THCs cream is beneficial in treating photo-damaged skin with no local systemic side effects.

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An open-label clinical study to evaluate the dermal safety and post-application effect of an oil control moisturizer


European J Biomed Pharmaceutical Sci. 2016;3(10):462–66.
Oily skin (seborrhoea) is one of the most common cosmetic complaints during adulthood, which is caused due to excess skin oil (sebum). And it is an important factor that could result in the formation of acne, oily scalp and comedo. Increased sebum secretion can also be seen during pregnancy and menopause because of hormonal imbalances, further leading to increased activity of sebaceous glands.

In oily skin, follicular reservoir is filled with large quantities of sebum, which further leaks onto the skin surface, thus making the skin look shiny, thick and dull-coloured with coarse pores, pimples and other blemishes. However, this condition peaks during adolescence and starts decreasing as you age.

Although several antibacterial cleansing lotions are available in the market, natural water-based, oil-free moisturizers are believed to be a safer bet. For example, policosanol, a natural sebum regulator, obtained from sugarcane wax and standardized to contain not less than 60% Octocosanol.

 

Objective:

To evaluate safety and efficacy of oil control moisturizer containing policosanol in participants with excess facial oiliness.


Study Design:

  • Seventeen healthy volunteers (male=8 and female=9; age: 18–50 years) were included in the current study
  • They were asked to apply the oil control moisturizer on their face in a circular motion, on cheeks, forehead and ala of nose, once per day for 2 weeks
  • Participants were followed-up regularly (i.e. on day 0, day 7 and 14) by the investigational team
  • Dermal safety was the primary outcome, while change in the skin appearance (i.e. reduction in face skin oiliness and soothing, and smoothing and softening effects) were secondary endpoints

Results and Discussion:

  • Oiliness of the skin was found to be drastically decreased by the end of the study when assessed using oily skin self-assessment scale (OSSAS) (Fig. 1A) and oily skin impact scale (OSIS) (Fig. 1B)
  • Similarly, number of oil absorbing pads used for wiping the facial oil was also reduced significantly upon application of the product in a time-dependent manner
  • "After effects" of oil control moisturizer was found to be excellent with 90% of participants experiencing much softer and smoother skin by the end of the study
  • Volunteers were also of the opinion that application of oil control moisturizer was beneficial
  • No adverse effects were reported by the volunteers

Conclusion:

Hence, it was concluded that application of oil control moisturizer containing policosanol was beneficial in controlling excess oiliness of the skin with smoother and softer skin in healthy volunteers.

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Efficacy of Centella asiatica extract in the management of cracked feet: in vitro and clinical evidence


World J Pharm Pharmaceutical Sci. 2016;5(12):983–94.
Cracked heels, a common foot problem, are often referred to as heel fissures. It is generally characterized by yellowing of skin on the heel, callused, growth of hard skin, flaky patches, cracked and peeling skin. Various factors like standing for longer duration, uncovered heels, diabetes (which facilitate dry skin formation) and certain skin conditions (e.g. psoriasis and eczema) are responsible for causing cracked heels. Under extreme conditions, cracked heels can be infection-prone, which may cause to cellulitis.

Herbal extracts like Centella asiatica have been traditionally known to play a critical role in the prevention and management of various health conditions, including wound healing. Several studies have also reported about its role in cell growth, collagen synthesis around wound sites, quicker epithelialisation and improving the tensile strength of newly formed skin around wounds and angiogenesis.

 


Objective:

To evaluate the safety and efficacy of Centellin® CG foot care cream, a formulation containing 2% Centella asiatica leaf extract, in the management of cracked heels in healthy female volunteers.


Study Design:

  • In this 28-day, split-controlled study, 24 participants (age: 18–40 years) presenting cracks or fissures in feet (especially in the heel region), associated with dryness, pain and roughness of the sole were included
  • Out of 24 participants, 12 were asked to apply fingertip unit of the Centellin® CG foot care cream on their right feet, whereas remaining 12 on to their left feet twice daily, and the untreated foot of each subject served as a control
  • All subjects were followed-up on weekly basis (i.e. day 7, 14, 21 and 28), were provided with study medication and were instructed to wash their feet properly before applying the cream
  • During each visit, participants were assessed for primary efficacy endpoint (i.e. number of cracks, scaling, pain and laxity of skin) as well as secondary endpoint (i.e. short and long-term safety, assessed by the incidence of adverse events)
  • Additionally, on day 28, volunteers independently rated the overall improvement on the following scale: 1- No changes, 2- Average, 3- Good, 4- Excellent, 5- Extremely Excellent

Results and Discussion:

  • Only 22 out of 24 participants completed the study (two dropped out citing personal reasons)
  • No incidence of adverse events were reported during the entire study period
  • At the end of the study, a significant reduction in the number of cracks in treated foot was observed, while moisturization benefits were seen improved (Fig. 1A and 1B, respectively)
  • From the photographs taken after 28 days of the study, a significantly improved visual change in the treated foot was witnessed
  • Overall product rating by participants revealed that product was satisfactory and well accepted (Good: 54.5%; Excellent: 22.7%; Extremely Excellent: 9%) (Fig. 2)

Conclusion:

Hence, it was concluded that Centellin® CG foot care cream can be effective in healing cracks and reducing the associated pain by virtue of its moisturizing, analgesic and collagen boosting properties.

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