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Completed

NCT Number: NCT07271628

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

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)

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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Skin Research Center

Toulouse, France, 31300

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cosmetic product AV0018B

Other

Cosmetic spray product AV0018B. The product is sprayed 6 times per day for 7 days. The spraying of about 3 sec is done on the inner and posterointernal side of the concerned forearm (according to randomization)

Primary outcomes

  1. Cutaneous Capacitance

    Time frame: - Visit 1 : Day 1 - Time 1 - Visit 2 : Day 8 - Time 2 (12±2hours after last application) and Time 3 (8±4hours after Time 2)

    Cutaneous capacitance is measured by Corneometry at posterointernal sides of forearms.

Secondary outcomes

  1. Illustrative Photographs

    Time frame: - Visit 1 : Day 1 - Time 1 - Visit 2 : Day 8 - Time 2 (12±2hours after last application) and Time 3 (8±4hours after Time 2)

    Photographs on posterointernal sides of forearms using the calibrated video camera and Moisture Map® tool, for illustrative purpose only.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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