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HealthyNCT07166484

Assessment of the Effect of the Product RV2666C Formula LA2984 Compared to an Untreated Area With an Epidermally Ablated Skin Model Obtained With an Erbium YAG Laser on Adults Presenting IV to VI Skin Phototype

An observational study of Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, we assess the efficacy of a cosmetic product in adults with IV to VI skin phototype. This study is conducted as a monocentric, controlled, compared with an untreated area and randomized for the area of product application. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Cosmetic product RV2666C LA2984
How many people
22 participants
Where
1 siteFrance
Study dates
15 Sep 2025to 5 Dec 2025
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The study is disseminated to the database of potential subjects by email and, if needed, by telephone, describing study title,name(s), address(es) and contacts of the study site(s), name of the Principal Investigator, the parameter(s) in study, study inclusion and exclusion criteria, study objective(s), groups of treatment, namely, if experimental or comparative products are tested, potential risks of adverse events and study duration. The subjects that manifested interest in participating in the study might be contacted by telephone. Screening questions are asked in order to screen the main inclusion and exclusion criteria Subjects' answers to the telephonic recruitment are evaluated by the Principal Investigator who decides if the subject is to be selected for the recruitment visit.

Main inclusion criteria :

  • Man or woman from 18 to 50 years old
  • Phototype IV to VI according to the Fitzpatrick classification
  • Subject smoking ≤ 10 cigarettes/day containing nicotine, paper or e-cigarette equivalent
  • Subject agreeing not to expose his forearms to UV (natural or artificial) throughout the duration of the study and up to 3 months after the end of participation in the study
  • Subject protected by a tetanus vaccination according to the vaccination schedule established by the Public Health Agency

Main non-inclusion criteria:

  • Subject suffering from a disease liable to affect the wound healing process according to the opinion of the investigator
  • Subject with a known history of allergy or contact dermatitis induced in particular by the latex, the plaster, the local anesthetic, the local antiseptic or one of the components of the study product
  • Subject with a disease including skin disease in progress on the upper limbs that may interfere with the interpretation of the evaluation criteria according to the opinion of the investigator
  • Topical or oral treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy or cutaneous tolerance of the investigational product according to the investigator's assessment

Trial locations and contacts

1 site in 1 country.

France1 site
  • Skin Research Center

    Toulouse, France, 31000

Other trials in France

About this study

In this study, we assess the efficacy of a cosmetic product in adults with IV to VI skin phototype.

This study is conducted as a monocentric, controlled, compared with an untreated area and randomized for the area of product application.

Read more

To perform this clinical study, minimum 20 - maximum 24 subjects (man or woman), aged from 18 to 50 years are enrolled.

The subjects applied the investigational product on an area located on the anterior side of the forearm, following the laser YAG act, once a day and under occlusion from Day 1 to Day 3 included. Then it is applied twice a day in an open way from Day 4 until Day 18 included.

10 visits are planned:

  • Visit 1: Inclusion visit = Day 1
  • Visit 2 to Visit 5: Intermediate visits = Day 2 to Day 5
  • Visit 6: Intermediate visit = Day 8
  • Visit 7: Intermediate visit = Day 10
  • Visit 8: Intermediate visit = Day 12
  • Visit 9: Intermediate visit = Day 15
  • Visit 10: End of study visit = Day 19-1
Conditions
Healthy
Being tested
Cosmetic product RV2666C LA2984

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cosmetic product RV2666C LA2984Other

    The product is applied, according to randomization, on an area located on the anterior side of the forearm, following the laser YAG act, once a day and under occlusion from Day 1 to Day 3 included. Then it is applied twice a day in an open way from Day 4 until Day 18 included.

Study groups in NCT07166484
Study groupRoleWhat they receive
Test GroupNot described
Receives: Other: Cosmetic product RV2666C LA2984

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to complete wound healing

    The wound disappearance is assessed by the investigator by clinical exam of the skin and from standardized photographs taken with a C Cube Caméra©.

    Measured: Day 1 - Visit 1, Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.

  2. The erythema of the skin

    The erythema of the skin is assessed objectively using treatment software from standardized photographs using a C Cube Camera©.

    Measured: Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.

  3. The pigmentation of the skin

    The pigmentation of the skin is assessed objectively using treatment software from standardized photographs using a C Cube Camera©.

    Measured: Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.

  4. The skin marks

    The skin marks are evaluated by the investigator at the end of the study using standardized photographs taken with a C Cube© Camera and using an NRS-type evaluation scale from 0 to 10.

    Measured: Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.

  5. The wound healing quality

    The wound healing quality is evaluated by the investigator at the end of the study using standardized photographs taken with a C Cube© Camera and using an NRS-type evaluation scale from 0 to 10.

    Measured: Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.

  6. The global efficacy of the product

    The global efficacy of the product is assessed by the subject with a 7-questions questionnaire.

    Measured: Day 19 - Visit 10

  7. The transepidermal water loss

    The transepidermal water loss is measured by a clinical research technician using a Vapometer©.

    Measured: Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.

  8. Standardized photographs in an illustrative purpose

    Photographs in 2D and 3D are taken using a C Cube Camera©.

    Measured: Day 1 - Visit 1 (before and after laser YAG act), Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start15 Sep 2025
  3. Primary completion5 Dec 2025
  4. Study completion5 Dec 2025

Resources

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166484
Sponsor's protocol ID
RV2666C20250434
Status last verified
May 2026
First submitted
3 Sep 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, 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?

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 5 May 2026. 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?

Time to complete wound healing (time frame: Day 1 - Visit 1, Day 2 - Visit 2, Day 3 - Visit 3, Day 4 - Visit 4, Day 5 - Visit 5, Day 8 - Visit 6, Day 10 - Visit 7, Day 12 - Visit 8, Day 15 - Visit 9 and Day 19 - Visit 10.). The study lists 8 primary outcomes in all. 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 5 May 2026.

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