Cosmetics Clinical Trials

The cosmetics industry is showing explosive growth  with the influx of cosmetic products and brands, amid such scenarios,  clinical evaluation of personal care and healthcare products becomes indispensable. The clinical testing of your cosmetic products not only authenticates your product claims but also ensures safety and efficacy of your cosmetic products thereby making your packaging and marketing more powerful and authentic. If your product claims are supported by robust evidence then your chances of a successful cosmetic business become a reality.

Cosmetics Clinical Trials

To meet the challenges of the marketplace, changing trends and ever-changing consumer needs, high quality, effective evaluation of your products is essential.

Clinical testing of your cosmetics and personal care products plays a crucial role in substantiating your product claims for packaging and advertising. It also ensures that your products are safe and effective for consumer use. In order to gain authenticity and trust of consumer and regulatory compliance it is highly important that your product claims are supported by robust evidence.

The responsibility of the safety of the test products remains with the manufacturers, this is why it is required that the testing organization should scrutinize all the safety aspects for both ethical and liability reasons. Cosmetic efficacy tests should be designed to be able to substantiate claims that are feasible for cosmetics in the specific regulatory framework.

The marketer has full responsibility for the safety of products. The expected manner of use should not be harmful for the health of the consumer. Claims and other information given to consumers regarding the cosmetic product must not be misleading.

Why do consumers look for clinical testing?

The new age consumers have become more demanding and advertising authorities have become more vigilant so it is important that your cosmetic product should go through clinical testing for cruelty free claims. The potential customers will be able to view real life results through the information provided to them along with graphic illustrations and detailed statistics. It ultimately helps the buyers to   understand the true benefits of a cosmetic product.

Clinical testing of your cosmetic product will give it an edge in the competitive market. Consumers tend to be skeptical about the claims of cosmetic products. This is why clinical trials assure real life results of using the cosmetic and it enhances the credibility and authenticity of your brand.

Impact of clinical trials

Clinical testing or clinical trials assess any effects that a cosmetic product might have on its consumers. It examines and considers the ingredients and their relevant toxicological endpoints and ensures that it is free from animal experimentation.

Clinical Trials for Real Life Results

Clinical trials can boost the credibility and popularity of your cosmetic products through efficacy testing, dermal safety, and cruelty free claims, PETA certification, and dermatologically tested products. The published test results make your product authentic among your target audience that will ultimately strengthen your cosmetic business.

Dermatologically Tested

A wide range of cosmetic products claims to be dermatologically tested. It means that the product was tested by a dermatologist on human volunteers for tolerance testing to ensure that it does not lead to severe skin reactions.

 A ‘dermatologically tested’ product indicates;

  • product has been tested on human skin
  • formula has been found to be mostly safe when applied to the skin.
  • The finished product was well tolerated by persons who tested it on their skin, and in most cases, it did not cause skin reactions.

Functional claims

The functional claims of cosmetic products which asserts that it reduces wrinkles, increases hair density or makes skin firmer in 7 days and several other such claims must not be misleading and it should be supported by scientific evidence and clinical trials.

Alternatives to animal testing

  •   Cell cultures
  •   Human tissues
  •   Computer models
  •   Volunteer studies
  •   Medical breakthroughs using humans

Our Clinical Trials and Safety Services

A glimpse at our wide array of clinical trials and safety services;

Cosmetic Products Safety and Efficacy studies

We ensure that your cosmetic products fulfill all the regulatory requirements and are safe for consumers. Right from the initial phase of product development to the final product we look towards all the aspects of the clinical process including clinical trials, product analytics. We provide an outright solution from base concept to publication and claim development.

Protocol Development and Medical Writing

We assist you in the design and development of most innovative protocols to get more information with a smaller study. Our team has more than 15 years of experience in protocol development and medical writing expertise. We Design / Develop a protocol for intended regulatory services.

Skin Irritation Tests
Skin Irritation Tests

Skin Irritation Tests

  • PIPT (Primary Irritation Patch Test)
  • HRIPT (Human Repeat Insult Patch Test)
  • As per BIS Standard 4011:2018
  • Clinical evaluation by a Dermatologist 
  • Safety in-use studies Test.
 

The claim of cosmetic products is being substantiated by using these devices;

Products for Skin Irritation Test

  • Rinse-off Products (eg. Face Wash, Hand Wash etc.)
  • Leave-on Products (eg. Creams, Lotions, oils etc)
  • Deodorants
  • Soap Bars
  • Talc/Powder
  • Sanitizers
  • Diapers
  • Tissue Wipes etc.
  • Hair dyes and other hair care products

Efficacy Studies

  • Fairness
  • Moisturisation
  • Oiliness
  • Acne
  • Instant Fairness
  • Skin Lightening
  • Skin Deodorant
  • Wrinkle Reduction
  • Skin Bleach
  • Anti-Inflammatory
  • Foot Crack Removal
  • Instant Brightness
  • Anti Itch
  • Anti Tan
  • Anti dandruff
  • Hair colors

Project Execution

  • Project planning
  • CTRI registration (as per sponsor’s recommendation)
  • Project implementation
  • Total Quality Assurance at each stage
  • Audits by internal as well as external auditors
  • Data Management and statistical Analysis
  • Preparation of Clinical study Report
  • Study close out process along with archival

Our standard instruments and devices

Our standard instruments and devices
Our standard instruments and devices

We use standard instruments in efficacy testing and claim support of cosmetics and personal care products. The devices are easy and quickly to use, thus perfectly suitable to study the product properties on the skin in each phase of the development process.

The claim of cosmetic products is being substantiated by using these devices;

Corneometer

Corneometer

This instrument is used to measure the hydration as the moisture content of the stratum corneum influences a number of skin characteristics including mechanical properties and barrier function.

Tewameter

Tewameter

It measures the assessment of the trans-epidermal water loss (TEWL). This parameter provides information on the integrity of the skin protective barrier functions. The measurements are performed by the application of a probe to the skin surface for 30 seconds.

Sebumeter

Sebumeter

The levels of sebum has been a subject of research. Sebum is produced across the whole of the body but varies significantly in amount. It has a bearing on how our skin appears and what effect products will have on the skin.

Mexameter

Mexameter

The Mexameter is a spectrometer measurement technique, based on light reflection and absorption. The probe emits three wavelengths of light, chosen to correspond to the different absorption rates of melanin and hemoglobin.

Cutometer

Cutometer

It is intended to measure viscoelastic properties (elasticity, firmness, tonicity and suppleness and anti-aging measurement) of the skin. The principle is based on a mechanical deformation of the skin via the suction method.

pH meter

Skin pH Meter

pH meter, electric device used to measure hydrogen-ion activity (acidity or alkalinity) in solution. Fundamentally, a pH meter consists of a voltmeter attached to a pH-responsive electrode and a reference electrode.

Facilities

  • Elegantly designed reception
  • Dedicated Enrolment Room
  • Separate desk for self-assessment
  • Dermatologist assessment cabins
  • Separate patch application area
  • Well-equipped skin evaluation area
  • Sufficient storage space for document as well as product archival
  • Spacious Conference room with two meeting rooms
  • Large volunteer waiting area
  • Provision for Individual informed consent process
  • Safety measures through well maintained fire-alarm system, fire extinguishers, Pest control, close circuit camera

Analytical Testing

We offer Import & Registration services and analytical testing of cosmetic products. The analytical testing is performed by our NABL accredited labs and currently there are 6 analytical labs in India to perform these tests.

Regulatory Compliance

We follow all relevant guidelines and regulatory guidelines. We are ISO 9001 accredited with an established and robust quality system managed by an experienced quality assurance team. Our analytical laboratories have been approved by NABL.

A Close Look at our Services and Expertise in Cosmetics Clinical Trial

Our team of clinical testing experts specializes in designing and conducting clinical testing methodologies from our network of laboratories in PAN India locations.

Our R&D network works together to discover and advance the most modern, scientific cosmetic testing methodologies in the world. Our toxicologists and safety experts analyze every cosmetic ingredient.  If needed, experiments are conducted using state-of-the-art in vitro tests and computer-based models to expand our understanding of the ingredient’s safety profile.

We also evaluate each ingredient to ensure that it meets the requirements of governmental, regulatory, and scientific bodies. We evaluate the safety of the ingredient as part of a cosmetic formula.

We work closely with you across the entire product life-cycle and help you ensure the product quality at each stage which is critical for market success. We provide analytical and quality control testing support during scale up and process validation studies and also conduct stability studies to establish the shelf life of your products.

Once the product goes into commercial manufacturing we support you with monitoring the manufacturing facilities, testing the raw materials, QC release testing of the products and ongoing stability studies. In the case of market complaints we also support you with full investigations to identify the cause, validity by testing the products and the ingredients used for manufacturing the particular batch.  

We also offer the services for supporting product development through dermatological efficacy testing and claims substantiation. The important areas include fairness, anti-aging, miniaturization, Oiliness, Acne, instant fairness, skin lightening, and skin deodorant.

We offer Total Quality Assurance expertise in generating robust data to support safety and efficacy and marketing claims. Our Cosmetic Clinical trials are focused on dermal safety studies to confirm the safety of skincare products during and after development including normal in-use safety studies, allergen potential and exaggerated use conditions.

If you would like to use our testing services please feel free to contact us through the contact form or call us now on +91-11-45754575. We will be happy to provide you with a proposal for your testing requirements.

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Once you fill out this form, you will:

1. Get an email or phone from our team to understand your exact requirement.
2. After that, a quotation catering to your requirement will be sent to your mail.
3. Once you approve the quotation, you can send us the sample for testing and we would provide you with the test report.