Clinical Studies Results
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*Disclaimer: Orofill Clinical Studies Results page is for professional use only. If you are our distributor or partner looking for more information, please contact us.

Table of Contents

Anti-inflammation of 

Omega 3 and 6

SeaBerry Oil has abundant omegas that could help to down regulate the inflammation at skin and systemic scale. The inflammation cascade showed the role of SeaBerry's omegas on activating the signaling molecules in the pro- and anti-inflammatory mediators.

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Eicosanoid is a large class of signaling molecules that include prostaglandins ( PG s ) ,thromboxanes, leukotrienes, mono-and poly-hydroxy fatty acids, and lipoxins. 


These compounds are produced from Ω3 and Ω6 PUFA by the action of enzymes known a scyclooxygenases (COX) andlipoxygenases(LOX). Eicosanoid is a complex mixture of anti- and pro-inflammatory effects.

Unsaturated Fatty Acids

Other 

Unsaturated 

Fatty Acids

Essential Fatty Acids

Omega 3

(α-linolenic acid)

Omega 6

(linoleic acid)

Omega 7

(palmitoleic acid)

Omega 9

(Oleic acid)

Serves an important immunomodulatory role.

Penetration enhancer at the epidermis layer by lipidfluidization and lipid phase separation

Rare fatty acids that is also a component of skin lipids.Stimulates regenerative process in the epidermis and promotes wound healing.

The most abundant PUFA present in the epidermis. It is aconstituent of intracellular cement. 

Directly correlates with permeability barrier function of the skin.

Cosmetic 2017, 4, 40; doi:10.3390/cosetics4040040. Author: Marijana Koskovac et all.

Strengthen Barrier Function

and Reduce Transepidermal Water Loss (TEWL)

Natural moisturizing factors (NMF) are elements that keep the epidermis protected and well-hydrated. With all the amino acids, fatty acids, triglycerides, phospholipids and sterols in Puredia SeaBerry®, they act as precursors to NMF to hold water in the stratum corneum and provide a barrier that sits on the surface of the skin to reduce TEWL.


In vivo: In a study with 60 healthy subjects, topical cream with 1 % SeaBerry Seed oil was used for 3 months. The skin hydration status and elasticity were determined using non-invasive instrumental measurements. Skin capacitance measured as corneometric units significantly increased during and at the end of the study. One-month application of SeaBerry Seed oil cream increased the capacitance of the skin by 30.5% (P < 0.001). This increase was maintained during the rest of the study period.

Hydratation
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B.Yang, A. Bonfigli, V. Pagani, T. Isohanni, Б. von-Knorring, A. Jutila, V. Jud. Effects of Oral Supplementation and Topical application of Supercritical CO2 extracted Sea Buckthorn Oil on Skin egging. J.Appl. Cosmetic, 27, 1-3 (January/March 2009)

Antioxidants

Skin aging can be divided into two types, intrinsic aging, and extrinsic photo-aging. The exposure to UVR is the main cause of oxidative stress in the skin. This is an important risk factor for development of skin problems. For example, wrinkle formation, lesions, and cancer. Upon exposure to sunlight, skin molecules absorb UVR resulting in the generation of reactive oxygen species(ROS). That exerts a damaging effect on cellular fractions including cell walls, lipid membranes, mitochondria, nucleus and DNA-producing oxidative stress.

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Mechanism of Aging
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N.K. Upadhyay a, R. Kumar a, S.K. Mandotra a, R.N. Meena a, M.S. Siddiqui b, R.C. Sawhney a, A. Gupta a. Safety and healing efficacy of Sea buckthorn (Hippophae rhamnoides L.)seed oil on burn wounds in rats. Food and Chemical Toxicology 47 (2009) 1146–1153

Phyto-antioxidants

The phyto-kingdom includes vegetables, fruits, whole grains and beverage. For example,tea, chocolate, and wine. These products are rich in natural antioxidant. Phyto-antioxidantincludes polyphenols and terpenes. These compounds play important roles in themetabolism and defense system of plants through their free radical scavenging potential.


With the β-carotene, vitamin C, vitamin E, superoxidedismutase (SOD) and flavonoids (isorhamnetin, quercetin,myricetin, kaempferol), Puredia SeaBerry® is one of thestrongest superfruits in the world with the oxygen radicalabsorbance capacity (ORAC) as high as 360,000μmol Te/100g. This antioxidant attribute may delay the agingprocess by removing the free radicals. It helps to alleviatedry, irritated, rough, flaking and itchy skin.

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Elasticity

In vivo: In a study with 60healthy subjects using topical cream with 1% of SeaBerry Seed oil for 3 months. Topical treatment with significantly increased the overall elasticity of the skin. After one and three months of treatment, overall elasticity was increased from the baseline by 18.6% and 21.9%, respectively, in the cream group. 


The clear increase in the overall elasticity and the decreasing trend in the visco-elasticratio demonstrated clear positive effects of the test products in improving the elasticity of the skin.



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Maximum deformation of the skin before, during and after supplementation of SeaBerry Oil capsule and topical application of SeaBerry oil cream

B.Yang,A. Bonfigli,V. Pagani, T. Isohanni, Б. von-Knorring, A. Jutila,V. Jud. Effects of Oral Supplementation and Topical application of Supercritical CO2 extracted Sea Buckthorn Oial on Skin egging. J.Appl. Cosmetic, 27, 1-3 (January/March 2009)


Saima Jaddoonet all. Anti-aging Potential of Phytoextract Loaded-Pharmaceutical Creams for Human Skin Cell Longevity. Volume 2015, Article ID 709626, 17 pages


Wound Healing Effects

Granulation tissue is composed of new blood vessels, collagen, and several cell typesincluding fibroblasts, myofibroblasts, and macrophages. VEGF appears to be a key factorin tissue repair that involves neovascularization as well as enhanced vascular permeability. SeaBerry in this study has shown the enhanced expression of VEGF.

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  Histology

Revealed increased blood vessels formation in the granulation tissue of SeaBerry Seed Oiltreated burn wounds (B). It also showed reduced congestion, edema and polymorpho-nuclearleukocytes (PMNLs) infiltration compared to the controlled burn wounds. Complete epithelialization with increased fibroblast and collagen deposition in the dermis was observed.

Histopathological changes of the skin wound section

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(A) Untreated burn control on eighthpost-wound day showing non-epithelialized (→) wound surface withslight edema and congestion.

(B) Skin wound section treated withSeaBerry Seed Oil. Neovascularization (BV) is well observed.

(C) Silver sulfadiazine treated burn wounds showing woundsurface with well-organized thickepithelium (→) and significant fibroblast and collagen depositionin deeper dermis.

N.K. Upadhyay a, R. Kumar a, S.K. Mandotra a, R.N. Meena a, M.S. Siddiqui b, R.C. Sawhney a, A. Gupta a. Safety and healing efficacy of Sea buckthorn (Hippophae rhamnoides L.) seed oil on burn wounds in rats. Food and Chemical Toxicology 47 (2009) 1146–1153

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Skin is maintained by a discrete architecture of cells and extracellular matrix, which serves as the principle barrier to environmental and infectious agents. Tissue injuries resulting from burns, disrupt this barrier, triggering a healing process. The wound healing process is categorized into three overlapping phases: inflammation, proliferation and tissue remodeling.

  Anti-inflammation

Inflammation plays an important role in fighting infection and inducing the proliferation phase necessary for healing. The fatty acids in sea buckthorn help to dampen inflammation to a healthycontrollable level. The SeaBerry Seed oil treated wound showed reduced or no edema, which maybe correlated with the faster contraction of the wound size. It could also attribute to increasedproliferation and transformation of fibroblast cells into myofibroblasts.

Pro-healing parameters: DNA, Total protein, Hydroxyproline, and Hexosamine
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Hydroxyproline is a marker of collagen content. It is a major extracellular matrix protein which confers strength and integrity to the tissue at the later phase of healing. The increased level of hydroxyproline provide strength to the regenerated tissue. Enhanced expression of collagen type-III as revealed through Western blotting signifies the increased collagen biosynthesis.

N.K. Upadhyay a, R. Kumar a, S.K. Mandotra a, R.N. Meena a, M.S. Siddiqui b, R.C. Sawhney a, A. Gupta a. Safety and healing efficacy of Sea buckthorn (Hippophae rhamnoides L.) seed oil on burn wounds in rats. Food and Chemical Toxicology 47 (2009) 1146–1153

  Vessels epidermal growth factor (VEGF)

Sebum Control and Anti-bacterial Effect

Acne Vulgaris is the most common skin condition that affects adolescent and young adults of 11 to 30 years of age. Acne Vulgaris is a multi-factorial disease affection the pilosebaceous follicles of the dermis. There are pathogenic factors involved in the development of acne: increase sebum production, follicular hyperkeratinization, microbial colonization (Staphylococcus Epidermidis and Propionibacterium Acnes) and the release of inflammatory mediators into the dermis. 


Sebum plays the key role in the development of acne. It is characterized by the formation of comedones, papules, pustules, cysts, nodules and often scars, primarily on the face and neck. The common treatments for Acne Vulgaris include oral and topical applications of comedolytic agents like benzoyl peroxide, azelaic acids, retinoids and oral/ topical antibiotics like tetracycline, erythromycin, and clindamycin. 


Based on the in-vitro anti-bacterial study, the result indicates that samples with 5% active of Hippophae Rhamnoides Extract had a stronger anti-bacterial activity as compared to C. fistula extracts again both bacteria(p.acne and s. epidermis) on the zone of inhibition.

H.rhamnoides formula used in the literature:

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Anti-bacterial activity (zone of inhibition [mm])

H. rhamnoides Extract (SeaBerry) 

Clidamycin

Propionibacteriu

Acne

Staphylococus

Epidermis

23.5 ±0.64

19.0 ±0.25

20.5 ±1.31

18.5 ±0.01

Values were based on triplicates and data presented as mean ± SD. For the column of eachsample, values followed by the same letter are not significantly different at p <0.05 (5%)

In the in-vivo study on 50 young adults with moderate facial Acne Vulgaris were tested for a period of 12 weeks. On the sebumetric analysis, the percent changes in the skin sebum contents following the treatment with the placebo has a mean initial change of 0.45% after the 1st week and the effect remained on a slight increasing mode after the 12th week up to 5.97% compared to the baseline sebum contents of the 25 volunteers. 

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On the other hand, the sebum contents were observed after the treatment with H. Rhamnoidesextract and showed a -7.32% mean initial reduction after the 1st week, -9.1% reduction after 1 month, and -21.13% reduction insebum contents at the end of the 12th week compared to baseline values.

SeaBerry® Seed Oil On Anti-bacterial activity (zone of inhibition [mm])

Number of Sample

Test Time

Test Bacteria

Bacteria Count of Control (cfu/ml)

Bacteria Count of Sample (cfu/ml)

Inhibition Rate (%)

WJ2016137-1

20 min

Propionbacterium acnes

2.33x10⁴

1.13x10³

95.15

*According to the standard: Inhibition rate ≥ 50∼90%, the product has inhibitory effect; inhibition rate≥90%, the product has strong inhibitory effect.

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5α-Reductase converts testosterone into dihydrotestosterone (DHT) which is more potent and results in theenlargement of sebaceous gland secreting a high amount of sebum. It is thought that inhibiting 5α-Reductase maybe effective in lowering the sebum level. Many botanical compounds are considered to inhibit 5α-Reductase. These include essential fatty acids (γ-linolenic acid,α-linolenic acid, linoleic acid and oleic acids) and phytosterols. Polyphenols and fatty acids inH. Rhamnoidescould help to reduce sebum contents by possibly inhibiting 5αreductase.

Department of Pharmacy, Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Bahawalpur, Pakistan Head of Department: Prof. Dr. Naveed Akhtar. Clinical and sebumetric evaluation of topical emulsions in he treatment of acne .Postępy Dermatologii i Alergologii 4,August / 2014vulgaris

Whitening Effect and Anti-tyrosinase activity 

Hyperpigmentation is one of the most common skin disorders. An increase in melanin synthesis or an irregular distribution of melanin results in hyperpigmentation or spots, especially on the face. Skin-lightening agents inhibit the conversion of tyrosine to melanin by the enzyme tyrosinase, thus tyrosin is the rate-limiting enzyme in melanin synthesis. Tyrosinase inhibitors play a vital role as skin-lightening agents.


This study uses 5% of H.rhamnoides extraction in the formulations and was tested in-vitro and in-vivo manner.

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Tyrosinase inhibitory effect [%]

H. rhamnoides Extract (SeaBerry)

Placebo

58.6 ±0.425

0



In vitro: Table below summarized the results of anti-tyrosinase inhibition activity as compared to control sample.

SeaBerry is rich in flavonoids, unsaturated fatty acids and antioxidants that have anti-tyrosinase activity. The reduction in skin melanin can be credited to these constituents present in the plant.


In-vivo: Single-blinded, placebo-controlled study to assess the effects of formulations on the improvement of the skin melanin in a group of 25 healthy subjects.

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Reduction in the skin melanin was noticed after the 12 weeks treatment with H.rhamnoides -3.5% mean initial reduction in melanin after the 1st week of treatment and -16.35 % reductions at the end of the 12th week compared to baseline values.

Percentage of changes produced in skin melanin after the application of:                        



(placebo) and (H. rhamnoides)

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A: Baseline photo of a patient treated with SeaBerry.

B: Clinical improvement seen after 12 weeks of therapy with SeaBerry

Barkat Ali Khan, Naveed Akhtar, Irshad Hussain, Khwaja Asad Abbas, Akhtar Rasul. Whitening efficacy of plant extracts including Hippophaerhamnoides and Cassia fistula extracts on the skinof Asian patients with melasma. Postępy Dermatologii i Alergologii 232 4, August / 2013

*Disclaimer: Orofill Clinical Studies Results page is for professional use only. If you are our distributor or partner looking for more information, please contact us.