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

NCT ID: NCT05837208

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2022-04-29

Brief Summary

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 .

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.

Conditions

Sunscreen

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treated Group

all subjects will apply the study product RV4369A

RV4369A cosmetic product

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thérèse Nocera, MD

Role: PRINCIPAL_INVESTIGATOR

Pierre Fabre Dermo Cosmetique

Locations

Skin Research Center

Toulouse, , France

Countries

France

Other Identifiers

ADPROTECTPF

Identifier Type: -

Identifier Source: org_study_id