Dry SkinNCT07271628
Evaluation of the Moisturizing Effect of Study Product AV0018B and the Persistence of This Effect After Repeated Applications, Compared to an Untreated Control Area.
An observational study of Dry Skin, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Dry Skin
- What is being tested?
- Cosmetic product AV0018B
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2021to 28 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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)
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- Not taking part in another clinical research study.
- Having signed the consent form.
- Having health insurance.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cosmetic product AV0018B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic product AV0018BOther
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)
| Study group | Role | What they receive |
|---|---|---|
| AV0018B application | Not described Receives: Other: Cosmetic product AV0018B | |
| No AV0018B application | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Capacitance
Cutaneous capacitance is measured by Corneometry at posterointernal sides of forearms.
Measured: - 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
Photographs on posterointernal sides of forearms using the calibrated video camera and Moisture Map® tool, for illustrative purpose only.
Measured: - 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start4 Oct 2021
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271628
- Sponsor's protocol ID
- MINIREGETA
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Moisturizing Effect of Study Product AV0018B and the Persistence of This Effect After Repeated Applications, Compared to an Untreated Control Area.
- ClinicalTrials.gov ID
- NCT07271628
- Acronym / sponsor ID
- MINIREGETA
- Conditions
- Dry Skin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AV0018B application | – | Other: Cosmetic product AV0018B |
| No AV0018B application | – | – |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic product AV0018BCosmetic 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) | Other | AV0018B application |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Skin, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.