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Description

Supervised In-Use Test under Dermatological & Ophthalmological Control

This study is a 21-day supervised in-use test with 20 volunteers, conducted under the joint oversight of a qualified dermatologist and ophthalmologist. The study includes comprehensive clinical evaluation and final sign-off from both specialists, providing robust data on product tolerance and performance for both skin and eye areas.

Products that are applied to the face—especially near the eyes—require evaluation across multiple exposure pathways. This dual-supervision study ensures that both dermal and ocular safety are assessed under realistic use conditions.

Study Purpose

This study evaluates how a product performs when used under normal conditions on the skin and around the eye area. It focuses on:

• Skin tolerance
• Ocular tolerance
• User comfort
• Cosmetic acceptability

It also helps determine whether repeated use may cause irritation, sensitivity, or discomfort in either area.

Study Design

The study follows a controlled, supervised in-use design over 21 days at a clinical site.

• 20 volunteers participate
• Product used under normal conditions according to instructions
• Dual supervision by dermatologist and ophthalmologist
• Clinical evaluations performed for both skin and eye areas
• Final sign-off provided by both specialists

This design ensures comprehensive safety assessment across intended use conditions.

Study Population

Participants are selected based on the intended product use.

All participants:

• Are in good general health
• Have no active skin or ocular conditions at study start

This allows for accurate assessment of product-related effects.

Evaluation Criteria

Clinical and subjective assessments are conducted throughout the study.

Dermatological assessments may include:

• Redness
• Dryness
• Irritation
• Sensations such as burning or stinging

Ophthalmological assessments may include:

• Eye redness
• Watering
• Irritation
• Discomfort

Participants also provide feedback on:

• Comfort during use
• Sensory experience
• Overall product acceptability

Both clinical observations and user feedback contribute to the final evaluation.

Claims Supported

This study can support a broad range of high-value marketing and safety claims, including:

• Dermatologist tested
• Ophthalmologist tested
• Dermatologically and ophthalmologically tested
• Clinically tested
• Tested under dermatological and ophthalmological control
• Suitable for use on face and around eyes
• Gentle on skin and eyes (subject to results)
• Non-irritating (subject to results)

Final claim support depends on study outcomes and regulatory considerations.

Data Review and Reporting

At the conclusion of the study:

• Data is summarized using descriptive analysis
• A clear and structured report is issued
• Final evaluation and sign-off from both dermatologist and ophthalmologist is included

The report is suitable for regulatory documentation, safety substantiation, and marketing support.

Why Choose Pentyl Labs

Pentyl Labs coordinates dual-supervision in-use testing with:

• Clear protocols
• Reliable timelines
• Easy-to-interpret reports
• Integration with broader testing programs

We also support related services such as HRIPT, safety assessments, and claims substantiation.

Get Started

Contact [email protected] to request a Supervised In-Use Test under Dermatological & Ophthalmological Control.