Evaluation of the Moisturizing Effect of Study Product AV0018B and the Persistence of This Effect After Repeated Applications, Compared to an Untreated Control Area.

Pierre Fabre

Status: Completed

Conditions: Dry Skin

Treatments: Other: Cosmetic product AV0018B

Study type: Observational

Funder types: Industry

Identifiers

NCT07271628

MINIREGETA

Details and patient eligibility

About

This study is a monocentric, intra-individual, controlateral design study, on the internal and posterointernal side of the forearms, to evaluate the moisturizing effect of study product AV0018B and of the persistence of this effect after repeated applications for 7 days, compared to a control area with no application of study product.

The study takes place over a 8-day period and involves 2 visits :

• Inclusion visit: Day 1 (1timepoint (Time 1) before any study product application)
• End-of-study visit: Day 8 (2 timepoints : Time 2 : 12±2h after last application , and Time 3 : 8±4h after Time 2)

Enrollment: 24 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females
• Aged 20 to 55 years, inclusive
• Phototype I to V, inclusive
• Low hairiness and absence of prominent veins on the internal and posterointernal side of the forearms.
• No shaving/hair removal of forearms
• Dehydrated forearms, with HI ≤ 35 (posterointernal side of the forearms)
• Not taking part in another clinical research study.
• Having signed the consent form.
• Having health insurance.

Exclusion criteria

Population:

• Pregnant, breastfeeding women.
• Subjects declaring to have hot flushes.
• With sunburn on forearms.
• Frequently washing their forearms for professional reasons or out of habit.
• Application of keratolytic and/or self-tanning products to the upper limbs in the 4 weeks prior to inclusion.
• Application of skin care (Hydrating, nourishing) or exfoliating products to the upper limbs in the 2 weeks prior to inclusion.
• Application of water or hygiene products to the upper limbs since the last wash on the evening before inclusion.
• Participating in another study on the forearms (not including kinetics studies) in the 2 weeks prior to inclusion.
• Participating in a kinetics study on the forearms in the 48 hours prior to inclusion.
• Subjects unable to comply with the protocol requirements.
• Subjects deprived of freedom through a legal or administrative decision, or in care or under legal guardianship.

Diseases:

• History of allergy to any of the investigational product ingredients
• Skin lesions or skin disease on the hands, arms and forearms.
• Type 1 diabetes.
• Unresolved viral hepatitis.
• Chronic cardiovascular, endocrine, rheumatological and urogenital system and non-stabilized neuropsychiatric disorders (treatment started less than 2 months ago).
• Acute pathology (infectious, inflammatory).
• Dermatological condition or skin lesion on the top of the cheekbone liable to interfere with the samplings according to the investigator's opinion.
• Any skin characteristic on the top of the cheekbone incompatible with the samplings (raised nevus, etc.) according to the investigator's opinion.

Treatments:

• Ongoing local treatment (dermocorticosteroids, retinoids, antibiotics, antifungals, etc.) or treatment applied in the 7 days prior to inclusion.
• Ongoing oral antibiotic and/or anti-inflammatory (steroid and non-steroid) or treatment taken for more than 5 consecutive days in the week before inclusion.
• Oral treatment (cardiovascular, endocrine, rheumatological, urogenital, neuropsychiatric, immunosuppressant) started in the 2 months prior to inclusion.
• Any local treatment applied to the face in the week preceding the inclusion visit
• Application of water, any rinsed or leave-on cleansing or care product on the face after the last wash performed the day before the inclusion visit

Trial design

24 participants in 2 patient groups

AV0018B application

Treatment:

Other: Cosmetic product AV0018B

No AV0018B application