Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Cosmetic Clinical Studies India | Safety & Efficacy Claim Substantiation

Claim with Confidence.

If you want to put "dermatologically tested", "clinically proven for sensitive skin", "12-hour waterproof", or "reduces wrinkles in 30 days" on your packaging, Auriga can generate the clinical data. 105+ studies completed. 530+ products tested. Instruments in-house. Dermatologists on-site.

Safety testing follows BIS 4011:2018 — Open Patch, Semi-Occluded, Occluded, and Short Duration Open Patch Testing — plus HRIPT per CTFA/PCPC. Efficacy testing covers anti-ageing, hydration, skin brightening, anti-dandruff, hair regrowth, lip moisturisation, and 12/24-hour wear validation for colour cosmetics — using Corneometer, Mexameter, Cutometer, Tewameter, Sebumeter, BTBP Clarity, DermLite, and expert Sniffer panels.

These are non-regulated studies under CDSCO — conducted under Independent Ethics Committee approval and dermatologist supervision. Data is accepted by the CDSCO Cosmetics Division, EU regulators (Cosmetic Regulation 1223/2009), and major Indian and international retail buyers for product claim substantiation. No CDSCO new drug approval is required.

Request a Study Proposal Call +91-7428116100

Proof, Not Promises

Documented experience that most competitor CROs cannot match — verifiable across categories, instruments, and dermatologist-led protocols.

105+

Clinical studies completed

530+

Products tested

9

In-house instruments & panels

BIS 4011:2018

Safety testing specification

Instrument → Claim Map

Every claim you want to make on packaging needs an instrument and a protocol behind it. Here is what we have in-house and what each one substantiates.

Corneometer CM 825

Skin hydration (stratum corneum capacitance)

Moisturising · Hydrating · Scar treatment

Mexameter MX 18

Melanin and erythema indices

Skin whitening · Radiance · De-pigmentation · Melasma

Cutometer Dual MPA 580

Skin elasticity, firmness, and viscoelasticity

Anti-ageing · Skin firmness · Rejuvenating

Tewameter TM Hex

Transepidermal water loss (TEWL) — barrier function

Skin barrier · Antiperspirant · Anti-pollution

Sebumeter SM 815

Sebum production on skin and scalp

Anti-dandruff · Pore refining · Anti-acne

BTBP Clarity (BrightTex)

Standardised high-resolution facial imaging

Wrinkle reduction · Texture · Pigmentation imaging

DermLite DL5

Polarised dermatoscopy for skin and scalp

Hair and scalp condition · Acne treatment imaging

Skin-pH-Meter

Skin surface pH measurement

pH-balanced · Mild · Sensitive-skin compatibility

Expert Sniffer Panel

Calibrated olfactory and sensorial assessment

Fragrance performance · Malodour reduction · Long-lasting scent

Safety Testing — BIS 4011:2018

Safety testing under BIS 4011:2018 and CTFA/PCPC protocols — dermatologist-supervised, Ethics Committee–approved, and accepted by CDSCO Cosmetics Division and major retail buyers.

Open Patch Test

BIS 4011:2018

Primary skin irritation screening for products applied freely on skin.

Semi-Occluded Patch Test

BIS 4011:2018

Intermediate-condition safety testing for leave-on cosmetics.

Occluded Patch Test

BIS 4011:2018

Worst-case exposure simulation for products under prolonged contact (e.g., patches, masks).

Short Duration Open Patch Test

BIS 4011:2018

Quick-screening protocol for low-residence-time products (rinse-off cleansers, wipes).

HRIPT

CTFA / PCPC

Human Repeat Insult Patch Test for allergic contact sensitisation — 50-200 subject panels.

In-Use / Consumer Trial

Auriga protocol

Real-life product use under controlled conditions with dermatologist tolerance grading and consumer self-assessment.

Product Categories We Test

From mass-market personal care to cultural cosmetics and emerging beauty devices — Auriga has dermatologist-led protocols across the full range.

Personal Care

Face cleansers · Body washes · Lotions · Moisturisers · Sunscreens

Hair Care

Shampoos · Conditioners · Hair oils · Serums · Anti-dandruff products · Hair regrowth

Lip Care

Lip balms · Lip glosses · Pigment correction · Long-lasting lip products

Color Cosmetics

Foundations · Concealers · Mascaras · Eyeliners · Lipsticks · 12h / 24h waterproof

Cultural Cosmetics

Kumkum · Sindoor · Bindi · Henna · Traditional cosmetic formulations

Baby Products

Baby lotions · Shampoos · Wipes · Powders · Diaper-rash products

Perfumes & Fragrances

Perfumes · Deodorants · Body sprays · Fragranced lotions · Malodour control

Beauty Devices

LED masks · Microcurrent devices · Hair-growth devices · Cleansing devices

Claims You Can Substantiate

A representative list of claims Auriga has substantiated for cosmetic and personal care brands. Custom claim protocols are designed during proposal scoping.

Dermatologically tested
Non-irritant
Safe for topical use
Clinically proven for sensitive skin
Hypoallergenic
Paraben-free / Sulfate-free (with testing support)
pH-balanced
Long-term skin compatibility tested
12-hour / 24-hour waterproof and smudge-proof
Clinically proven anti-ageing
Clinically proven skin brightening
Clinically proven hair regrowth support

Arbro Group Clientele

Clients associated with the Arbro Group across formulation, clinical research, testing, and manufacturing include:

MamaearthL'OréalMankindPiramal HealthcareGlenmarkHamdardCaffeineNingenPlixSanfeHyphen

These clients are associated with the Arbro Group across multiple services — they are not exclusively Auriga clinical-study clients.

Related Services

CRO Services Overview Full CRO capabilities Phase II–IV Clinical Trials Pharma regulated trials Cosmetics Testing Lab BIS · Stability · Heavy metals · Microbiology Cosmetics Stability Testing ICH Q1A · Accelerated + real-time CDMO / Personal Care Formulation · Private label · Manufacturing Cosmetics Industry Hub End-to-end services for brands

Frequently Asked Questions

How many cosmetic clinical studies has Auriga completed?
Auriga has completed 105+ cosmetic clinical studies across 530+ products with Ethics Committee oversight and dermatologist supervision. Studies span personal care, hair care, lip care, colour cosmetics, cultural cosmetics, baby products, perfumes, and beauty devices.
Are cosmetic clinical studies regulated by CDSCO?
Cosmetic claim-substantiation and efficacy studies in India are non-regulated under CDSCO drug rules — they are conducted under Independent Ethics Committee approval and dermatologist supervision following ICMR ethical guidelines. Safety testing follows BIS 4011:2018 and CTFA/PCPC protocols. Data generated by Auriga is accepted by CDSCO Cosmetics Division, EU regulators (Cosmetic Regulation 1223/2009), and major Indian and international retail buyers for product claims. No CDSCO new drug approval is required.
Which instruments does Auriga use for cosmetic efficacy studies?
In-house instruments include Corneometer CM 825 (hydration), Mexameter MX 18 (melanin and erythema), Cutometer Dual MPA 580 (elasticity), Tewameter TM Hex (transepidermal water loss / barrier), Sebumeter SM 815 (sebum), BrightTex BTBP Clarity (facial imaging), DermLite DL5 (dermatoscopy), Skin-pH-Meter (surface pH), and a calibrated expert Sniffer panel for olfactory and sensorial studies.
What is BIS 4011:2018 and why does it matter?
BIS 4011:2018 is the Bureau of Indian Standards specification for the safety evaluation of cosmetic products. It defines patch-test protocols — Open Patch, Semi-Occluded, Occluded, and Short Duration Open Patch Testing — used to demonstrate that a cosmetic product is non-irritant and safe for topical use. Auriga conducts BIS 4011:2018 testing under dermatologist supervision with Ethics Committee approval. Reports support "dermatologically tested" and "non-irritant" claims on packaging.
Which claim types can Auriga substantiate?
Safety claims (dermatologically tested, non-irritant, hypoallergenic, sensitive-skin tested, paraben-free / sulfate-free with testing support), efficacy claims (moisturising, hydrating, skin whitening, anti-ageing, anti-dandruff, anti-acne, hair regrowth, wrinkle reduction, skin firmness, scar treatment), and performance claims (12-hour / 24-hour waterproof, smudge-proof, long-lasting fragrance, antiperspirant, malodour reduction).
Can Auriga support "12-hour waterproof" and "24-hour smudge-proof" claims for colour cosmetics?
Yes. Auriga validates 12-hour and 24-hour waterproof / smudge-proof claims through controlled in-use trials with standardised challenge conditions (water exposure, rubbing, sweat simulation) and instrumental and clinical grading at defined time points. Studies meet the substantiation evidence expected by retail buyers and advertising standards bodies.
How long does a cosmetic clinical study take?
Single-time-point safety patch tests typically complete in 4-6 weeks. HRIPT studies are 9 weeks standard. Cosmetic efficacy studies range from 4 weeks (immediate effects like hydration) to 12 weeks (anti-ageing wrinkle reduction). Hair growth studies typically run 16-24 weeks. Detailed timelines are provided during proposal scoping.
Which clients has the Arbro Group worked with?
Clients associated with the Arbro Group across formulation, clinical research, testing, and manufacturing include Mamaearth, L'Oréal, Mankind, Piramal Healthcare, Glenmark, Hamdard, Caffeine, Ningen, Plix, Sanfe, Hyphen, and others. These clients are associated with the Group across multiple services — they are not exclusively Auriga clinical-study clients.

Substantiate Your Cosmetic Claims with Confidence

105+ studies · 530+ products · BIS 4011:2018 safety · Corneometer, Cutometer, Mexameter, Tewameter, Sebumeter, BTBP, DermLite, Skin-pH-Meter in-house · Dermatologists on-site.

+91-7428116100 Request a Study Proposal

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