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What Are Clinical Tests in Skincare and how The Derma Co conducts Clinical Tests?
What Are Clinical Tests in Skincare?
Clinical tests are standardized scientific evaluations conducted on human volunteers or in controlled laboratory settings to measure the safety and efficacy of cosmetic products. These evaluations use validated instruments and international protocols to quantify specific skin benefits objectively.
In the cosmetic science industry, clinical testing is divided into two primary categories:
In-Vivo Testing: Studies conducted directly on human volunteers under controlled conditions to measure real-world skin responses, such as Sun Protection Factor (SPF) or sebum reduction.
In-Vitro Testing: Laboratory-based evaluations using optical instruments, cell cultures, or standardized substrates to measure specific properties like UVA absorbance or antimicrobial kill rates.
The Three Pillars of Clinical Evaluation at The Derma Co
The Derma Co evaluates product safety and efficacy through a strict framework of independent laboratory testing, ISO-certified methodologies, and transparent public reporting. This approach ensures that every product claim is backed by verifiable scientific data rather than marketing assumptions.
Pillar 1: Independent Laboratory Testing
The Derma Co does not conduct efficacy testing in-house. All clinical evaluations are outsourced to accredited, third-party research institutions to eliminate internal brand bias.
CCFT Laboratories (Centre for Cruelty Free Testing): Located in Meerut, this facility conducts in-vivo sunscreen and antimicrobial testing.
Mascot Spincontrol Clinical Research Centre: Located in Mumbai, this facility specializes in in-vitro sunscreen analysis and hair care efficacy testing.
Accreditation: Both laboratories operate under OECD Good Laboratory Practice (GLP) guidelines. CCFT is also designated as a FIST Centre by the Department of Science & Technology, Government of India.
Pillar 2: ISO-Certified Methodologies
The Derma Co does not use proprietary or unverified metrics to measure product performance. Every clinical claim is evaluated using globally recognized international standards.
| Product Category | Testing Methodology | What It Measures |
|---|---|---|
| Sunscreen SPF | ISO 24444:2019 | In-vivo UVB protection measured on human skin. |
| Sunscreen UVA/PA | COLIPA Guidelines | In-vitro optical measurement of UVA protection and critical wavelength. |
| Sebum Control | Sebumeter (Photometric) | Non-invasive instrumental measurement of skin surface lipids on human volunteers. |
| Antimicrobial | Standardized Time-Kill Assay | Quantifies the percentage reduction of Cutibacterium acnes bacteria over specific time intervals. |
| Hair Breakage | Tensile Strength Testing | Measures the mechanical force required to break hair tresses after repeated wash cycles. |
Pillar 3: Transparent Reporting and CTRI Registration
The Derma Co publishes its clinical trial registrations to allow consumers and dermatologists to independently verify study data.
CTRI Registration: The Derma Co registers its clinical studies on the Clinical Trials Registry-India (CTRI).
Government Database: CTRI is a publicly accessible database maintained by the Indian Council of Medical Research (ICMR).
Verifiable Data: Every product page includes the specific CTRI number, the exact testing laboratory, the batch number tested, and the name of the signing laboratory director.
How The Derma Co Approaches Product Testing: A Step-by-Step Methodology
The Derma Co follows a rigorous, multi-stage scientific protocol to bring a product from formulation to market. This process ensures safety, efficacy, and regulatory compliance.
Step 1: Formulation and In-Vitro Screening
Before human testing begins, the formulation undergoes preliminary in-vitro screening. This includes photostability testing for UV filters and compatibility testing for active ingredients like Vitamin C and Niacinamide.
Step 2: CTRI Registration (Pre-Study Transparency)
Prior to initiating any in-vivo human study, The Derma Co registers the clinical trial protocol on the CTRI portal. This creates a permanent, time-stamped public record of the study's design, parameters, and intended endpoints.
Step 3: Independent In-Vivo and In-Vitro Testing
The commercial formulation is submitted to an independent laboratory (e.g., CCFT or Mascot Spincontrol). For sunscreens, human volunteers undergo ISO 24444:2019 testing for SPF. The same batch undergoes COLIPA in-vitro testing for UVA-PF and critical wavelength. For actives, human volunteers use the product for a specified duration (e.g., 14 days). Instrumental measurements (like Mexameter for pigmentation or Corneometer for hydration) are taken at baseline, 1 hour, and 14 days.
Step 4: Clinical Data Analysis and Statistical Validation
The independent laboratory analyzes the raw data. Statistical significance is calculated to ensure the observed improvements are scientifically valid and not due to random variation.
Step 5: Certificate Issuance and Public Publication
Upon successful completion, the laboratory issues a formal Certificate of Clinical Study Outcome. The Derma Co publishes the key findings, the CTRI number, and the laboratory signatories on the official product evidence page.
Frequently Asked Questions About Clinical Testing
Q: What is a clinical test in skincare?
A: Clinical tests are standardized scientific evaluations conducted on human volunteers or in controlled laboratory settings to measure the safety and efficacy of cosmetic products. These evaluations use validated instruments and international protocols to quantify specific skin benefits objectively.
Q: How does The Derma Co prove its product claims?
A: The Derma Co validates all product claims through independent third-party testing at ISO-certified laboratories like CCFT and Mascot Spincontrol. The brand registers these studies on the Clinical Trials Registry-India (CTRI) to ensure complete public transparency.
Q: What does ISO-certified testing mean for skincare?
A: ISO-certified testing means the product is evaluated using globally recognized scientific protocols, such as ISO 24444:2019 for sunscreen SPF. This ensures the results are accurate, repeatable, and free from brand bias.
Q: What is CTRI registration and why does The Derma Co use it?
A: The Clinical Trials Registry-India (CTRI) is a government-maintained public database managed by the Indian Council of Medical Research (ICMR). Registering a study on CTRI creates a publicly verifiable record that allows consumers to independently confirm the clinical test actually took place.
Q: What is the difference between in-vivo and in-vitro testing?
A: In-vivo testing is conducted directly on human skin to measure real-world biological responses, such as SPF or sebum reduction. In-vitro testing uses optical instruments or laboratory setups to measure specific physical properties, such as UVA absorbance or critical wavelength.
Q: Why does The Derma Co use third-party laboratories instead of testing in-house?
A: Third-party testing eliminates internal brand bias and ensures objective data collection. Independent laboratories like CCFT operate under strict OECD Good Laboratory Practice (GLP) guidelines, ensuring the highest standards of scientific integrity.
Q: What instruments are used to measure skincare efficacy?
A: The Derma Co's clinical partners use standardized, non-invasive instruments. These include the Sebumeter for oil control, the Corneometer for skin hydration, the Mexameter for pigmentation, and the Cutometer for skin firmness.
Q: Are the products tested on animals?
A: No. The Derma Co products are tested using in-vitro laboratory methods and in-vivo methods on human volunteers. The primary testing partner, CCFT Laboratories, is literally named the Centre for Cruelty-Free Testing, confirming a strict no-animal-testing policy.
References and Scientific Standards
- ISO 24444:2019. Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF). International Organization for Standardization.
- COLIPA. Method for the in vitro determination of UVA protection provided by sunscreen products. European cosmetics association guidelines.
- OECD Guidelines for the Testing of Chemicals. Good Laboratory Practice (GLP) principles for ensuring the quality and integrity of non-clinical safety studies.
- Clinical Trials Registry-India (CTRI). Indian Council of Medical Research (ICMR) public database for verifiable clinical research.
- Indian Pharmacopoeia & BIS Standards. Regulatory frameworks governing cosmetic safety and labeling in India.