Determination of Product Thickness Applied on Different Areas of the Face Using a Multispectral Imaging Method

Determination of the Thickness Truly Applied of the SPRAY50+ on Different Areas of the Face Estimated by a Multispectral Imaging Method, After Application of the Product With and Without Recommendations of Use by a Group of Healthy Subjects

The aim of the study is to determine:

• the thickness of the RV4369A truly applied on different areas of the face after single application of the product determined by a multispectral imaging method.
• the influence of a second application of the product 15 to 30 minutes after the first application on the product thickness determined by multispectral imaging method.
• the influence of the recommendations of use provided to the subjects before application of the product on the product thickness determined by multispectral imaging method .

Study Overview

• Status: Completed
• Conditions: Sunscreen
• Intervention / Treatment: Other: RV4369A cosmetic product

Detailed Description

This study is a monocentric, comparative, open study performed on the face and forearms of healthy adults.

Planning of the visits:

Visit 1: Inclusion visit (D1) Visit 2: End of study visit (D10), a window of +/- 2 days is allowed for this evaluation, * The theoretical study duration for each subject is 10 days. The maximal study duration for each subject is 12 days.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Skin Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Panel of healthy volonteers

Description

Inclusion Criteria:

• Dry, normal to combination skin
• Phototype I to V inclusive.
• Absence of significant facial hair.

Exclusion Criteria:

Population

• Pregnant, breastfeeding women.
• For men: moustached or bearded.
• Substantial hair on the forearm and face.
• Application of keratolytic or self-tanning products to the face, forearms and arms in the four weeks prior to inclusion.
• With scars or other cutaneous characteristics, sunburn on forearms in the test areas, the size of which is considered incompatible with the study.
• Application of water, cleansing or beauty products to the forearms and arms since the last wash on the evening before inclusion.

Diseases :

• Known history of allergy to any of the investigational product ingredients.
• Known history of allergy to latex.
• Skin lesions or skin disease on the face or on the arms and forearms that may affect test results (seborrheic dermatitis, atopic dermatitis, psoriasis, acne, rosacea, etc.).

Treatments:

• Ongoing local or Oral treatment (retinoids, anti-inflammatory) that may affect test results.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Treated Group; all subjects will apply the study product RV4369A

Other: RV4369A cosmetic product; The product is applied 1 or 2 times during the 2 study visits. The product is recovered by the technician after application of the product by the volunteer. Application modalities: Inclusion Assessment: The study product is given to the volunteer who applies it to his face (forehead) according to his usual habits. After a waiting time and Multispectral camera measurements, the study product is again applied by the volunteer to his face according to his usual habits. Final assessment: The study product is applied by the Clinical Research Technician on the subject's forearm on 4 delimited areas at specific quantities. After a waiting period and Multispectral camera measurements on the forearm areas, the study product is given to the volunteer who applies it on his face according to the recommendations of use provided by the Technician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amounts of sun spray applied to the face, measured by multispectral imaging after single application by the subject	The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique	Visit 1 (Day 1)
Amounts of sun spray applied to the face, measured by multispectral imaging after 2 applications by the subject	The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique	Visit 1 (Day 1)
Amounts of sun spray applied to the face, measured by multispectral imaging after 1 application by the subject and according to the recommendations of use provided by the technician	The product quantity applied by the subject (mg/cm2) will be extrapolated from a reference curve build using an image analysis technique	Visit 2 (Day 10)
Comparisons between measurements of sun spray amounts determined by multispectral imaging	Comparaisons between an application without recommendations of use (Visit 1), an application without recommendations followed by a second application (Visit 1) and an application according to the recommendations of use (Visit 2)	Visit 1 (Day1) and visit 2 (Day 10)

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Thérèse Nocera, MD, Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): April 29, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ADPROTECTPF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No