Clinical Trials for Cosmeceutical and Checklist for Outsourcing

1
CLINICAL TRIALS FOR COSMECEUTICAL AND CHECKLIST
FOR OUTSOURCING
A presentation by Dr. Nancy Agnes, Head,
Technical Operations, FoodResearchLab Group
www.foodresearchlab.com Email info_at_foodresearchla
b.com
2
Introduction

• Cosmetics are a fast-expanding sector, and
  theres no denying that cosmeceutical products
  play a major role in modern day care.
• With record-breaking sales since the early 2000s,
  the cosmeceutical sector has grown to be a
  sizable consumer-driven market, with US9.7
  billion in sales in 2011 and US12.3 billion in
  sales predicted by 2025.
• The origin of cosmeceutical can be traced back to
  about 30 years ago, coined by Albert Kligman.
  They comprise a list of products that possess
  biological ingredients with drug like advantages.
• It may not be permissible to use the terms
  evidence-based and cosmeceutical together.
• Therefore, their active ingredients should have a
  solid scientific rationale based on human
  clinical trials findings.

3

• There are two common types of Cosmeuticals are
  available in the market
• 1. Drug form
• 2. Over the Counter
• The growing desire to appear younger and
  healthier has led to enormous commercial
  opportunities and has taken on global importance.
• Social media and the internets influence have
  increased public knowledge of the health
  advantages of natural products made from plants
  and other natural resources as well as the
  concerns connected to the use of various
  chemicals in cosmetics.
• The cosmetics business is currently focusing more
  on natural goods as a result.
• This is where Guires FRL CDMO can be great
  problem-solvers for you, we are pioneers in
  cosmeceutical product formulation and development
  from plants and botanical extracts.

4
(No Transcript)
5
Less Evidence Base

• Since the cosmetic industry is not bound to
  federal regulations under FDA rules and there is
  no necessity to exhibit premarketing safety or
  efficacy.
• Hence millions of extracts derived from botanical
  and synthetic sources can be fused into
  cosmetics.
• It is therefore appropriate to determine the
  benefits and downsides of treatments that are
  readily accessible commercially and that
  dermatologists prescribe, considering the
  abundance of treatments with questionable
  efficacy.
• Finding frequently used products that make claims
  about their effectiveness and safety is also
  crucial. Consumers are searching for a magical
  solution that is affordable, easy to use, and
  effective more than ever.
• Dermatologists frequently visit consumers who
  inquire about new products that promise to remove
  wrinkles in only one week or if certain products
  are useful.

6

• Understanding the composition and functionality
  of human skin is necessary to address these
  questions with a clinically and scientifically
  accurate technology.
• For proper evaluation of a novel cosmeceutical
  product, claiming to have a beneficial effect, it
  is critical to ask the following four questions

• Does the active ingredient have good penetration
  to stratum cornea and find its way to the
• intended target cell at adequate
  concentration and understand its action
  mechanism?
• 2. Can we understand the biochemical mode of
  action on the target
• cell?
• 3. Is the beneficiary supported by strong
  evidence from peer-
• reviewed, placebo-controlled,
  double-blinded, and statistically
• substantial clinical trials?
• 4. Does it have a low risk profile?

7

• This iterates the need for extensive clinical
  research should be followed cosmeceutical product
  development that is to be placed on the market.
• The development of cosmeceuticals, particularly
  composite active ingredients, should be grounded
  in their well-defined sources, structures, and
  interactions with the skin above all, it should
  be based on their safety and effectiveness when
  applied to the specific skin components.
• Hence for cosmetic products to carry a
  clinically tested claim, it is important to
  undergo rigorous clinical trial conforming to the
  standards set by Food and Drug Administration
  (FDA).
• In the view of rising global challenges from
  Brexit to Russia-Ukraine war, volatile
  international relations, occurrence of pandemics
  and so on, has caused several delays and issues
  in research and drug development cycle.
• clinical trials is seen as a blessing in disguise
  by many companies since it allows them to reduce
  costs.

8
CHECKLISTS TO BE FOLLOWED
Even though there are many pros in outsourcing
clinical trials, it does come with a lot of risks
such as transparency and confidentiality issues,
unseen delays among several others, Hence
selecting the right outsourcing contract research
organisation (CRO) is crucial. Let us look at a
few important points to be followed while
outsourcing a cosmeceutical clinical trial as per
FDA is as follows

• Overview of the Company Check historical
  background, financial stability, ability of the
  CRO to manage projects under unforeseen
  circumstances.
• Quality Accreditations for CROs All current and
  past certifications and licenses like Good
  clinical practice (GCP), Good Laboratory practice
  (GLP), National Accreditation Board for Testing
  and Calibration Laboratories (NABL), etc.
• Investigational site and investigator
  relationships CRO should have a larger database
  with excellent bond with investigators is
  essential for easy site selections and study
  completion.
• Infrastructure and Technology Ensure the CRO has
  the latest technology and research tools to carry
  out the clinical trial within the stipulated
  period

9
Conclusion

• The concept is by no means novel or false to
  suggest that substances originating from nature
  can be curative or even reverse illness
  processes.
• Limited cosmeceuticals comprise active
  ingredients with evidence-based corroboration of
  efficacy. But with more consumers starting to
  become more intelligent about product and
  marketing claims, substantial evidence is being
  required.
• Hence there is an urgent need for effective and
  efficient cosmeceutical clinical research
  management.
• This is where Guires FRL CDMO comes into the
  picture. We have a team of experienced and talent
  professionals who develop trials which aim to
  prove the safety of product, efficacy,
  substantiate the specific advertising claims and
  help your business standout from the competition.
• With a variety of study options, including
  consumer perception surveys, safety and efficacy
  studies, randomized-controlled trials, we at
  Guires FRL CDMO help in streamlining and easing
  the process of evaluating skincare products.
  Speak with us right now to experience the impact
  of scientific validation.

10
REFERENCES

• Emily C. MilamEvan A. Rieder (2021). An
  Approach to Cosmeceuticals. Essential Psychiatry
  for the Aesthetic Practitioner, (), . doi
  10.1002/9781119680116.ch4
• Desai, S., Patel, N. (2021). Checklist to
  select contract research organization for early
  phase bioavailability/bioequivalence clinical
  studies in healthy adult human volunteers.
  Research Journal of Pharmacology and
  Pharmacodynamics, 13(4), 131-142.
• Monteiro, Erica de O Baumann, Leslie S (2006).
  The science of cosmeceuticals. Expert Review of
  Dermatology, 1(3), 379389. doi10.1586/17469872.1
  .3.379
• Liu, J. K. (2022). Natural products in cosmetics.
  Natural Products and Bioprospecting, 12(1), 40.

11
CONTACT US
UNITED KINGDOM
44- 161 818 4656
INDIA
91 9566299022
EMAIL
info_at_foodresearchlab.com