Clinical Skin Compatibility Evaluation of a Cosmetic Face Cream

FREE SHIPPING on orders over $150

Background

Modern dermocosmetic products are expected to combine comfort, efficacy, and excellent tolerance. To support confident everyday use, finished-product skin compatibility should be verified using standardized clinical methodology under controlled conditions.

Objective

To confirm the skin compatibility of AVL Face Cream Light (Face Cream Ref: F-FC-004-1.0) using standardized single-application occlusive patch testing and quantitative irritation scoring (M.C.I.I.). 

Methods

Two independent monocentric, simple-blind patch test studies were conducted under dermatological supervision at an external clinical investigation center. The product was applied pure (undiluted) under 48-hour occlusion using an occlusive Finn Chamber® system. Irritation potential was quantified using the M.C.I.I. based on erythema and oedema scoring at defined timepoints.

Results

AVL Face Cream Light demonstrated M.C.I.I. values of 0.08 (sensitive skin cohort, n=54) and 0.13 (normal skin cohort, n=55), both classified as Non-irritating (<0.25).

Conclusion

Under standardized high-challenge occlusive conditions with pure product application, AVL Face Cream Light exhibited excellent skin compatibility in both sensitive and normal skin cohorts.

Introduction

Skincare formulas are getting more complex

Modern dermocosmetic formulations increasingly combine multiple active ingredients to enhance performance. However, combining numerous bioactive components - particularly at meaningful concentrations - introduces potential concerns regarding cumulative or synergistic irritation effects.

The scientific question is straightforward
Does increasing formulation complexity proportionally increase irritation risk?

Single-application occlusive patch testing is widely used as a first-line compatibility assessment because it:

Standardizes dose, exposure time, and evaluation methodology
Creates a controlled high-challenge scenario (48-hour occlusion)
Quantifies irritation potential using a validated cumulative index (M.C.I.I.)

This methodology serves as a structured clinical compatibility gate prior to broader consumer-use testing and claim substantiation.

The present publication summarizes two standardized patch test studies of Eye Cream conducted in sensitive and normal skin cohorts.

Safety Assessment & Application Protocol

Study Design

Type: Single-application occlusive patch test

Design: Monocentric, simple-blind

Supervision: Dermatological control

Setting: Independent external clinical investigation center

Application Protocol

Dose: 20 µL

Product state: Pure (undiluted)

Application system: Occlusive Finn Chamber® (8 mm / 50 mm²)

Exposure duration: 48 hours

Assessment timepoints:

30 minutes post-removal
24 hours post-removal

Outcome Measure

Skin reactions were evaluated according to predefined numerical grading scales for:

Erythema (E) — redness

Oedema (O) — swelling

Cohorts	Age Range	Phototypes	Subjects	M.C.I.I	Classification
Sensitive Skin	18–70	I–IV	54	0.08	Non-irritating
Normal Skin	18–70	I–IV	55	0.13	Non-irritating

* Interpretation Scale (Max possible value: 6)

* Both cohorts independently met the Non-irritating classification threshold (<0.25).

Regulatory and Ethical Compliance

The studies were conducted:

Under dermatological supervision
In accordance with the Declaration of Helsinki (1964) and subsequent updates
Following ICH E6 (R2) Good Clinical Practice principles
Within the framework of Regulation (EC) No 1223/2009 on Cosmetic Products
In alignment with Commission Regulation (EU) No 655/2013 (cosmetic claims)
Under GDPR compliance (Regulation (EU) 2016/679)
Within a documented quality management system consistent with internationally recognized standards (e.g., ISO 9001)

Results Discussion

AVL Face Cream Light formulation integrates a diverse active profile, including a full complement of 21 amino acids and multiple botanical and skin-supportive ingredients. Despite this complexity, the product demonstrated very low cumulative irritation values in both normal and sensitive skin cohorts.

The tested Face Cream Light integrates:

Bifida Ferment Lysate
Niacinamide
Urea
Butyrospermum Parkii Butter (shea butter)
Persea Gratissima Oil
Pyrus Malus Seed Oil (apple seed oil)
Mangifera Indica Seed Butter

Rather than assuming compatibility based on ingredient-level safety, the finished formulation was evaluated under controlled, standardized conditions using a 48-hour occlusive patch-test model — a recognized high-challenge scenario for assessing acute irritation potential.

The observed M.C.I.I. values of 0.08 (sensitive skin) and 0.13 (normal skin) fall well below the 0.25 threshold for Non-irritating classification. These results were consistent across two independent cohorts representing.

Tested at Full Strength

PATCH TESTING IS ONE OF THE CLEANEST FIRST ANSWERS BECAUSE IT:

✓ Pure (Undiluted)

✓ Under Occlusion

✓ Uredefined classification thresholds

✓ Using predefined classification thresholds With quantitative scoring methodology

References

European Parliament & Council. (2009). Regulation (EC) No. 1223/2009 on Cosmetic Products, Official Journal of the European Union. This regulation sets out the legal framework for cosmetic safety assessment in the EU, including requirements for demonstrating product safety prior to market placement.
Scientific Committee on Consumer Safety (SCCS). (2021). Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation (11th Revision, SCCS/1628/21). European Commission. Provides scientific guidance on safety evaluation of cosmetics and ingredients under EU law, including considerations on human data for local effects.
Api, A. M., et al. (2021). Draize human repeat insult patch test (HRIPT): Seven decades of protocols and standardization challenges. Toxicology in Vitro. Highlights variability and historical evolution of HRIPT approaches relevant to skin compatibility assessment.