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

NCT05837208 | Completed

• 1 other identifier: ADPROTECTPF
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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 .

Conditions

Sunscreen

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

Treated Group

all subjects will apply the study product RV4369A

Other: RV4369A cosmetic product

Interventions

RV4369A cosmetic product 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.

Treated Group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Panel of healthy volonteers

You may qualify if:

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

You may not qualify if:

• Population
• Pregnant, breastfeeding women.
• For men: moustached or bearded.
• Substantial hair on the forearm and face.
• With scars or other cutaneous characteristics, sunburn on forearms in the test areas, the size of which is considered incompatible with the study.
• 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.

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Center

Toulouse, France

Location

Study Officials

• Thérèse Nocera, MD

  Pierre Fabre Dermo Cosmetique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: April 4, 2022
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

FR (1)