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

NCT07271628 | Completed

• 1 other identifier: MINIREGETA
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Dry Skin

Outcome Measures

Primary Outcomes (1)

• Cutaneous Capacitance

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

  - 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)

Secondary Outcomes (1)

• Illustrative Photographs

  - 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)

Study Arms (2)

AV0018B application

Other: Cosmetic product AV0018B

No AV0018B application

Interventions

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)

AV0018B application

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the panel of the centre (corresponding to an internal computer database whose software has been declared to the Commission Nationale Informatique et Libertés (CNIL)). If necessary, a local announcement/advertising will be done. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Center

Toulouse, France, 31300, France

Location

Study Design

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

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 9, 2025
• Study Start: October 4, 2021
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

FR (1)