Clinical trial NCT05837208: Determination of Product Thickness Applied on Different Areas of the Face Using a Multispectral Imaging Method
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sunscreen
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Panel of healthy volonteers

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.

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.

Primary outcomes:
measure: Amounts of sun spray applied to the face, measured by multispectral imaging after single application by the subject
timeFrame: Visit 1 (Day 1)
measure: Amounts of sun spray applied to the face, measured by multispectral imaging after 2 applications by the subject
timeFrame: Visit 1 (Day 1)
measure: 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
timeFrame: Visit 2 (Day 10)
measure: Comparisons between measurements of sun spray amounts determined by multispectral imaging
timeFrame: Visit 1 (Day1) and visit 2 (Day 10)
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Skin Research Center
Study officials:
affiliation: Pierre Fabre Dermo Cosmetique
name: Thérèse Nocera, MD
role: PRINCIPAL_INVESTIGATOR
References: