Ingredient Research / Claim Substantiation and Customer Research Trials - Retinol

Claim Substantiation
Product Retinol Gold Facial Serum
Qualitative research analysis based on
evidence, statistic and research.



Aqua, Sodium Hyaluronate, Simmondsia Chinesis (Jojoba) Seed Oil, Aloe Barbadensis Leaf Juice Powder, L-ascorbic acid, Tocopheryl Acetate, Retinol (Vitamin A), Preservative K (Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate Tocopherol), Xanthan Gum, Citric Acid.

Product Claims to be Substantiated:

1) Targets the first signs of ageing such as wrinkles, sagging skin and dullness. 2) Retinol helps you to naturally produce collagen which reverses the effects of ageing and sun damaged skin. 3) Targets Pigmentation, Uneven skin tone and dark circles:


There are hundreds of studies which look into Retinol’s (Vitamin A) effectiveness on wrinkles notably the study By Kafi et al (2007) which used elderly human subjects to test whether topical application of 0.4% retinol solution made a difference to their skin in terms of ageing.

They found that …

‘’Topical retinol improves fine wrinkles associated with natural aging. Significant induction of glycosaminoglycan, which is known to retain substantial water, and increased collagen production are most likely responsible for wrinkle effacement. With greater skin matrix synthesis, retinol-treated aged skin is more likely to withstand skin injury and ulcer formation along with improved appearance.’’
‘’Wrinkles and brown spots that represent aged features are accentuated in the habitually sun-exposed face and the back of the hands. In this premature skin aging (ie, photoaging), matrix degradation triggered by solar radiation is critical in causing the wrinkled phenotype, and topical use of retinoids can offer clinical improvement.’’
Reference: Reza Kafi, MD; Heh Shin R. Kwak, MD; Wendy E. Schumacher, BS; et al (2007) Improvement of Naturally Aged Skin With Vitamin A (Retinol).

Researchers in Japan tested retinol on wrinkles around the eyes on human subjects with wrinkles (crows feet) using two different serums in their study – one with retinol and one without. The found a remarked difference and reduced wrinkles in the subjects who had been using the product with retinol.
Reference: Akira KAWADA, Natsuko KONISHI, Tomoyuki MOMMA, Naoki OISO, Shigeru KAWARA (2009) Evaluation of anti‐wrinkle effects of a novel cosmetic containing retinol using the guideline of the Japan Cosmetic Industry Association.

Bellemere et al studied the antiaging efficacy of retinol using doses of between 0.4–1.6% retinol and found that even on doses as low as 0.1% increased keratinocyte proliferation and epidermal thickness, improved all major aging signs assessed in our study (wrinkles under the eyes, fine lines and tone evenness), promotes keratinocyte proliferation ex vivo and in vivo, induces epidermal thickening ex vivo and alleviates skin aging signs, without any significant adverse reaction.
Bellemère G.a · Stamatas G.N.b · Bruère V.b · Bertin C.b · Issachar N.b · Oddos T.a (2009) Antiaging Action of Retinol: From Molecular to Clinical

Researchers looked at topical application of retinol in concentrations of 0.5% to 1% in order to study the substances effect on photodamaged skin using topical, daily application. The studied the efficacy of the product in both formulations and the results showed ‘’In the observational pilot study, most participants showed improvement in overall photodamage, crow's feet, elasticity, wrinkles, brightness, and hyperpigmentation at 60 to 80 days’’ and The topical formulation of retinol improves photodamaged skin for at least 8 to 12 weeks. This shows us that retinol is effective at targeting these concerns.
Gold MH1,  Kircik LH,  Bucay VW,  Kiripolsky MG,  Biron JA (2013) Treatment of facial photodamage using a novel retinol formulation

4) Renews Skin Faster / stimulate the production of new skin cells

Bellemere et al studied the antiaging efficacy of retinol using doses of between 0.4–1.6% retinol and found that even on doses as low as 0.1% accelerated skin cell proliferation.
Bellemère G.a · Stamatas G.N.b · Bruère V.b · Bertin C.b · Issachar N.b · Oddos T.a (2009) Antiaging Action of Retinol: From Molecular to Clinical

Kang, Studied the receptors or Retinol in the skin which show how Vitamin A enters a cell and can be esterified and stored, or can be sequentially oxidized to all-trans retinoic acid. Retinol he defined as any molecule that, by itself or through metabolic conversion, binds to and activates the retinoic acid receptors, thereby eliciting transcriptional activation of retinoic acid-responsive genes that results in specific biologic responses; showing that alongside collagen production it also helps cells grow back healthy.

 Sewon Kang (2005) Mechanism of action of retinol

Two double-blind studies versus vehicle were carried out to investigate the effects of a topically applied retinol plus vitamin C combination on epidermal and dermal compartments of aged or photoaged human skin. The two studies were performed on postmenopausal women who were selected for treatment based on the mild level of elastosis of their facial skin. At completion of treatment, skin biopsies were collected and processed for classical histology and immunohistochemistry. In the first study (aged skin), 8 volunteers applied the retinol- and vitamin C-containing preparation on the ventral side of one elbow and the vehicle on the other elbow twice daily for 3 months. After the 3-month treatment we observed histological changes mainly within the epidermis. The stratum corneum was thinner with a compact pattern, whereas the epidermal proliferation increased, resulting in a thickening of the viable epidermis. Moreover, the interdigitation index was increased. In the second study (photoaged skin), 11 volunteers were divided in two groups; one applied the retinol- and vitamin C-containing preparation and the other one the vehicle on their face twice daily for 6 months. Facial skin samples presented histologic hallmarks of photoaging, i.e. accumulation of elastotic material in the papillary dermis. After the 6-month topical treatment, the observed histological changes were mainly concentrated at the dermal level. Both treated and control groups showed the same distribution pattern of type I procollagen, however, the high level of type III procollagen originally observed in photoaged skin was reduced in the retinol- and vitamin C-treated group, resulting in a lower type III-to-type I procollagen ratio. Furthermore, a wide band of eosinophilic material just beneath the epidermis, devoid of oxytalan fibers and forming the ‘grenz zone’, appeared more frequently and was larger in the retinol- and vitamin C-treated group. In conclusion, our results show that repeated topical application of a preparation containing both retinol and vitamin C is able to reverse, at least in part, skin changes induced by both chronologic aging and photoaging.
Seité S. · Bredoux C. · Compan D. · Zucchi H. · Lombard D. · Medaisko C. · Fourtanier A. (2015) Histological Evaluation of a Topically Applied Retinol-Vitamin C Combination

5) Contains Hyaluronic Acid to attract moisture to the skin.

Researchers in Greece looked at and studied Hyaluronic Acid in its structural form and explain that in aqueous solutions Hyaluronic Acid forms specific stable tertiary structures which can hold high quantities of water and benefit tissue by aiding its hydration levels. ‘’Youthful skin retains its turgor, resilience and pliability, among others, due to its high content of water.’’. At a molecular level these structures have space filling tendencies and in a cosmetic product would therefore plump the skin at the same time.

They explain in their study that […] Hyaluronic Acid in the dermis […] is in continuity with the lymphatic and vascular systems. HA in the dermis regulates water balance, osmotic pressure and ion flow and functions as a sieve, excluding certain molecules, enhancing the extracellular domain of cell surfaces and stabilizes skin structures by electrostatic interactions.
Eleni Papakonstantinou, Michael Roth & George KarakiulakisDepartment of Pharmacology; School of Medicine; Aristotle University of Thessaloniki; (2012) Hyaluronic acid: A key molecule in skin aging

Researchers studied Hyaluronic Acid as a vehicle for permeability to deliver a ‘’transdermal carrier for active lipophilic ingredient’’ in order to assess the bioavailability of the substance. They used a certain alcohol free, oil/water based nano-emulsion with hyaluronic acid that could permeate into the dermis and successfully found that it worked favourably to deliver the active lipophilic ingredient into the skin. Which shows that Hyaluronic acid not only works inside the skin pt hydrate and plump, but also has the function to penetrate the dermis to deliver skincare ingredients deeper into the skin intercellular and follicular pathways.

.MingKongaXi, GuangChenbDong, KeonKweoncHyun, JinPark (2011) Investigations on skin permeation of hyaluronic acid based nanoemulsion as transdermal carrier.

Other researchers studied hyaluronic acid alongside other ingredients to help soothe some side effects and effectively deliver other ingredients to the skin. Their study which was published in the Journal of Cosmetic Dermatology involved 34 participants taking isotretinoin and a gel-cream containing hyaluronic acid and 33 participants (also taking isotretinoin) a placebo cream. Oral and topical retinoids are infamous for causing dryness and irritation, but after three months, the group that got the HA gel-cream showed improved hydration, less acne, and less trans-epidermal water loss than the placebo group. These results suggest that an HA-containing cream can be useful for mitigating the side effects of retinoids or substances known to cause dryness by drawing water into the molecule which sits in the skin and dermis.

María Isabel Herane MD  Héctor Fuenzalida MD  Emilia Zegpi MD  Carolina De Pablo QF Maria José Espadas MS  Carles Trullás MS  Alfons Mirada MD  Guillermo González Martin QF (2009): Specific gel‐cream as adjuvant to oral isotretinoin improved hydration and prevented TEWL increase – a double‐blind, randomized, placebo‐controlled study

 

In another study, this one published in 2014 in the Journal of Cosmetic and Laser Therapy, 23 women applied a serum containing HA and human growth factor (proteins found naturally in the body) twice a day for eight weeks. Compared with their original baseline, participants showed an improvement in signs of aging—specifically, wrinkles around the eyes—after eight weeks.
Do Hyun Lee, In Young Oh, Kyo Tan Koo, Jang Mi Suk, Sang Wook Jung, Jin Oh Park (2014): Improvement in skin wrinkles using a preparation containing human growth factors and hyaluronic acid serum.

Retinol is converted to retinoic acid when applied to the skin when its absorbed. The following stufy looked at the effects of retinoic acid and hyaluronic acid on skin cells by applying both ingredients to cells and harvesting the culture samples for microscopy to analyse changes. They found that ‘’Retinoic acid caused a marked change in the epidermal tissue architecture. The epidermal cells were flattened and contained fewer desmosomes and tonofilaments than control explants. Retinoic acid induced accumulation of fine granular material in the intercellular spaces in the upper, and less dense, flocculent material.’’ Meaning cells were smoother and more refined. It also induces the synthesis of new intercellular material, at least a part of which is hyaluronic acid.’’ Which shows that the ingredients can be used together to improve skin texture and in synthesis.  It also demonstrates that RA leads to an accumulation of HA in the superficial layers of epidermis by stimulating its synthesis in keratinocytes
Raija Tammi  Markku Tammi (1986): Influence of retinoic acid on the ultrastructure and hyaluronic acid synthesis of adult human epidermis in whole skin organ culture

J Clin studied human subjects between 30 and 60 years of age with signs of wrinkles. They were asked to apply various molecular weights of 0.1% HA cream including 50, 130, 300, 800 and 2000 kDa. After one month they found that treatment with 130 kDa HA was the most effective, increasing skin elasticity by 20%. Both the 50 and 130 kDa group had significant improvement in wrinkle depth and skin roughness after 60 days. All the other molecular weights still improved elasticity and skin hydration,.

This graph is a breakdown of the various percentages and molecular weights of HA on skin hydration against the Relative Water content of the skin over time.
J Clin Aesthet Dermatol. (2012) Efficacy and Safety of a Low-Molecular Weight Hyaluronic Acid Topical Gel in the Treatment of Facial Seborrheic Dermatitis

‘’ Skin moisturizing is one of the key aims of the commercially available skin care products. In order to keep the skin in good condition the cosmetic formulations should contain active compounds which are able to bind water and hence are responsible for water retention. One of the most widely applied active ingredient showing such properties is hyaluronic acid. Its physicochemical and biological properties are responsible for proper tissue hydration and transport of ions and nutrients.’’
‘’HA is a highly hygroscopic biopolymer. Each glucuronic acid unit contains a carboxyl group, giving rise to polyanionic character at physiological pH. Therefore, in the presence of water, hyaluronic acid molecules can expand in volume (1000 times) and can form a network stabilized by hydrogen bonds. One HA molecule can bind to approximately 250 water molecules (1 g of HA retains 6 l of water). Hyaluronic acid is nontoxic, non- irritating and non-sensitizing because it occurs naturally in skin.’’

Anna OLEJNIK, Joanna GOŚCIAŃSKA, Izabela NOWAK – Faculty of Chemistry, Adam Mickiewicz University, Poznań (2012): Significance of hyaluronic acid in cosmetic industry and aesthetic medicine

After significant research, case studies, trials and appropriate scientific scalable studies we think that the claims made by us regarding retinol and Hyaluronic Acid are well within the bounds of accuracy and are in no way inflated, presumptuous or misleading. Retinol has clearly been shown to reduce and improve ageing skin, wrinkles, photodamage. We have stated ‘targets’ rather than ‘will reduce’ so as to not make any specific promises to the consumer, or promise them any timescales for specific results.

The Purpose of this qualitative research was in order to conduct a qualitative and sometimes quantative in-depth study of the product ingredient’s to support their cosmetic claims for the purpose of advertising, marketing and sales purposes in line with the European Regulation 655/2013 as detailed below. We have elaborated where necessary our viewpoint on the specific topics.

 ‘’Product claims of cosmetic products serve mainly to inform end users about the characteristics and qualities of the products. Those claims are essential ways of differ­ entiating between products. They also contribute to stimulating innovation and fostering competition.’’


Section One: Legal compliance.

(1) Claims that indicate that the product has been authorised or approved by a competent authority within the Union.

N/A For this product and is compliant.

 (2) The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product, who is reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors in the market in question.

People who are in the beauty aisle shopping for skincare will be well aware of the products function (hydrating and anti-ageing) based on the information on the front of the packet and its claims. A young teen for example would not be interested in this product and would be extremely unlikely to pick it up. Being a cosmetic cultural, linguistic and social factors are unlikely to be an alter the perspective of the product in any way.

(3) Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements shall not be allowed.

N/A For this product and is compliant.

Section two: Truthfulness

(1) If it is claimed on the product that it contains a specific ingredient, the ingredient shall be deliberately present.

All ingredients mentioned in the marketing claims are key and deliberate ingredients.

(2) Ingredient claims referring to the properties of a specific ingredient shall not imply that the finished product has the same properties when it does not.

The ingredients used in this product and the simple formulation was designed to bring out the benefits of the ingredients and in a way that complements each other and in effect increase the efficacy of the ingredients. For example, the retinol and hyaluronic acid molecules are dissolved in distilled water and made smaller in order for them to penetrate and absorb into the dermis effectively whereas using them on their own would not allow this. Special care has been taken to word the claims in a way that does not insinuate that this is pure retinol or pure hyaluronic acid and does not make any claims to suggest this.

(3) Marketing communications shall not imply that expressions of opinions are verified claims unless the opinion reflects verifiable evidence.

We have taken all research into consideration before marketing any claims and do not make any which has not been backed up by science and studies on human subjects. To do this would be against our companies ethics, standard and practices.

Section Three: Evidential support

(1) Claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments.

We do not make any product claims without first looking at research on ingredient benefits and only use ingredient formulations which are known to be effective in what they’re aiming to achieve fort the consumer.

(2) Evidence for claim substantiation shall take into account state of the art practices.

All research we look at is carried out by relevant scientists and researchers who use state of the art technology and analysis to test their subjects.     

(3) Where studies are being used as evidence, they shall be relevant to the product and to the benefit claimed, shall follow well-designed, well-conducted methodologies (valid, reliable and reproducible) and shall respect ethical considerations.

All studies we looked at study the Retinol and Hyaluronic in a cosmetic context, using real skin application so its relevant and applicable to our claims.

(4) The level of evidence or substantiation shall be consistent with the type of claim being made, in particular for claims where lack of efficacy may cause a safety problem.

All levels of efficacy needed in the ingredients are well researched and the ingredients in their respective quantities or lack of efficacy do not pose any safety problems.

(5) Statements of clear exaggeration which are not to be taken literally by the average end user (hyperbole) or statements of an abstract nature shall not require substantiation.

N/A to this product or claim made.

(6) A claim extrapolating (explicitly or implicitly) ingredient properties to the finished product shall be supported by adequate and verifiable evidence, such as by demonstrating the presence of the ingredient at an effective concentration.

We look at product efficacy and ingredient percentages before making a claim in all new product development and before highlighting what the product does. We assess the nature of the products usage when generating a formula and decide on acceptable levels per ingredient to make an effective product in line with European Safety standards. If we find that an unsafe amount of ingredient is needed to make the product effective then we do not use it, similarly if a safe percentage of an ingredient is ineffective at what it does then we do not use it and would look for an alternative.

 

 

(7) Assessment of the acceptability of a claim shall be based on the weight of evidence of all studies, data and information available depending on the nature of the claim and the prevailing general knowledge the end users.

As per above studies.

Section 4: Honesty

(1) Presentations of a product’s performance shall not go beyond the available supporting evidence.

We have not made any claims which are not supported or go beyond available studies. For example we use the word ‘Target’ as this is not making any specific promises to the consumer other than they it can be used for these issues.

(2) Claims shall not attribute to the product concerned specific (i.e. unique) characteristics if similar products possess the same characteristics.

N/A to these claims.

(3) If the action of a product is linked to specific conditions, such as use in association with other products, this shall be clearly stated.

N/A For this product

Section five: Fairness

(1) Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used.

N/A For this product and is compliant.

(2) Claims for cosmetic products shall not create confusion with the product of a competitor.

L 190/34

Official Journal of the European Union

11.7.2013

N/A For this product and is compliant.

 

  Section Six: Informed decision-making

(1) Claims shall be clear and understandable to the average end user.

We do not use complicated Jargon, misleading claims, misrepresented statements or exaggerated adjectives in our claims. We use simple statements to inform the consumer about the products benefits and how it can improve their skin in a clear and concise way.

(2) Claims are an integral part of products and shall contain information allowing the average end user to make an informed choice.

We developed this product in order to improve skin so it’s important to us to highlight this through product claims otherwise the product would have no use or selling points to the end consumer; so we highlight what the product does to the skin based on the scope of available research in order for them to pick a product which they need/want.

(3) Marketing communications shall take into account the capacity of the target audience (population of relevant Member States or segments of the population, e.g. end users of different age and gender) to comprehend the communication. Marketing communications shall be clear, precise, relevant and understandable by the target audience.

As our products are skincare and cosmetics; our marketing communications are appropriate for all consumers and specific people or groups would not be misled into buying the products. We do not coerce or shroud our claims in any mystery.

In line with CAP and ASA Guidelines and rules this product does not use claims such as leading”, “best”, or “cheaper” than any other brands of similar products.


Claims regarding the nature of experimental studies (Annex II of Technical document on cosmetic claims)

 

1. ‘‘tolerance tested’’

 

The claim and 'tolerance tested' means that the product underwent tests under the supervision of a scientifically qualified professional intended to study its tolerance on a target group and that the results of those tests show that the product was well tolerated by this group.”

N/A to this product – we do not claim this.

2. ‘’tested under medical supervision"

 

’The claim 'tested under medical supervision' indicates that the product underwent tests conductedunder the supervision of a medically qualified professional, such as a medical doctor or a dentist. Depending on the presentation of the claim, it may, for example, refer to a specific efficacy of the product or skin tolerance.

N/A to this product – we do not claim this.

 

3. ‘’dermatologically tested’’

 

‘’The claim 'dermatologically tested' implies that the product was tested on humans under the supervision of a dermatologist. Depending on the presentation of the claim, it may refer to a specific efficacy or tolerance of the product. Consumer self-perception studies are not appropriate to support such claims. The same logic would apply to a claim referring to any other medical discipline.’’

N/A to this product – we do not claim this.

 

4. ‘’clinically tested’’

 

‘’The claim 'clinically tested' refers to expertise, process or conditions under which the tests were carried out. 'Clinically tested' means that the product was tested on humans under the supervision of a medically qualified professional or another scientifically qualified professional according to a clinical protocol or in a clinical setting.’’

N/A to this product – we do not claim this.

'Free from' Claims
N/A to this product – we do not claim this.

'Natural' and 'organic' Claims

The terms 'natural' and 'organic' are not specifically regulated under the CPR, which controls the safety of cosmetic products. However, the provisions for cosmetic claims in Article 20 of the CPR and the Common Criteria apply equally to these claims as well.

The ISO Standard 16128 provides guidance on the definition of 'natural' and 'organic' (ISO 16128-1), and how to calculate the % of naturalness of ingredients in finished cosmetic products (ISO 16128-2). There is no legal requirement to comply with the ISO guidelines, it is a company decision.

N/A to this product – we do not claim this.

'Hypoallergenic' Claims

N/A to this product – we do not claim this.

'Not Tested on Animals' Claims

N/A as this is common law.

'Vegan' Claims

There is no legal definition of a vegan or vegetarian cosmetic product. Manufacturers may include claims that the product does not contain any animal-derived ingredients at all or is "suitable for vegans". Such claims are acceptable, but it is a legal requirement that all claims can be substantiated and are not misleading to the consumer.
N/A to this product – we do not claim this.

Halal

N/A to this product – we do not claim this.