Re-epithelialization Efficacy Evaluation of Cosmetic Product RV1551P vs Non-treated Forearm of Healthy Adult Women

NCT ID: NCT06387277

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2022-12-12

Brief Summary

The aim of this study was to evaluate the impact of the product RV1551P GB3224 on skin microbiota during wound healing process, based on swab samples collected from lesion areas using an epidermally ablated skin model of erbium YAG laser.

Detailed Description

This study is a monocentric, open-label, intra-individual, controlled and randomized study conducted in 21 healthy adults.

A comparison is done between areas treated with the product RV1551P GB3224 and untreated areas (randomized arms).

The swab samples are performed on 4 study areas: 2 areas on the volar aspect of each forearm identified Z1, Z2, Z3 and Z4. Two areas are epidermally ablated with an erbium YAG laser at Visit 1 (D1) with a surface around 6cm² (Z1 and Z3): one area is treated with the product RV1551P GB3224 and the other one is untreated. On these areas, four swab samples are performed: at Day 1 before and after the laser act at the inclusion visit (V1-D1), at Day 5 (V4-D5), at visit corresponding to complete wound healing (re-epithelialization time) and at the end of study (V9-D19).

Two healthy areas (Z2 and Z4), with a surface around 6cm², are identified on each forearm. One of these areas is treated with the product RV1551P GB3224. On these areas, two swab samples are performed: at the inclusion visit (V1-D1), and at the end of study (V9-D19).

Conditions

Healthy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Arms of healthy female from 20 to 45 years old

It is a randomized intra-individual comparative study where two areas of the skin are ablated using an erbium YAG laser at Visit 1, with a surface area of approximately 6cm² (Z1 and Z3). Additionally, two healthy areas (Z2 and Z4), with a similar surface area, are identified on each forearm. The study involves comparing the areas treated with the product RV1551P GB3224 to the untreated areas (randomized arms).

RV1551P GB3224

Intervention Type: OTHER

RV1551P GB3224 Approximately 2 mg/cm² of product is applied to the Z1 or Z3 study areas (randomization).

From D1 to D2, a single product application is done at the study center by the subject in the presence of the clinical research technician (CRT) after epidermal ablation with an erbium YAG laser. After application, a dressing is placed on the measurement area and removed the following day at the center on D2 and D3 by the CRT before measurements.

From D3 to D18, two product applications are done with a minimum 4-hour interval:

• On visit days (D3, D5, D8, D10, D12, D15): an application is done at the study center by the subject in the presence of the CRT after measurements. A second application is done at home in the evening.
• On non-visit days (D4, D6, D7, D9, D11, D13, D14, D16, D17, D18): the subject applies 2 product applications at home (morning and evening).

Subjects receive the product at the end of visit 3 and return it at the last visit (visit 9).

Interventions

RV1551P GB3224

RV1551P GB3224 Approximately 2 mg/cm² of product is applied to the Z1 or Z3 study areas (randomization).

From D1 to D2, a single product application is done at the study center by the subject in the presence of the clinical research technician (CRT) after epidermal ablation with an erbium YAG laser. After application, a dressing is placed on the measurement area and removed the following day at the center on D2 and D3 by the CRT before measurements.

From D3 to D18, two product applications are done with a minimum 4-hour interval:

• On visit days (D3, D5, D8, D10, D12, D15): an application is done at the study center by the subject in the presence of the CRT after measurements. A second application is done at home in the evening.
• On non-visit days (D4, D6, D7, D9, D11, D13, D14, D16, D17, D18): the subject applies 2 product applications at home (morning and evening).

Subjects receive the product at the end of visit 3 and return it at the last visit (visit 9).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Criteria related to the population:

• Male or female, from 20 to 45 years old included.
• Phototype I, II or III according to the Fitzpatrick classification.
• Subject smoking ≤ 10 cigarettes / day containing nicotine, paper and/or electronic 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.
• If the subject is a woman of childbearing age:

i. Subject who used an effective method of contraception, evaluated by the investigator for at least 8 weeks before inclusion in the study.

ii. Subject agreeing to continue using it during all the study and up to 5 days after the last products application, in order to avoid pregnancy during exposure to the study products.

• Absence from participation in a clinical research protocol.
• Signature of the informed consent form.
• Affiliation to social security scheme or beneficiary of such a scheme.

2. Criteria related to treatment:

• Subject protected by a tetanus vaccination according to the vaccination schedule established by the Public Health Agency.

Exclusion Criteria

1. Criteria related to the population:

• Pregnancy or breastfeeding ongoing or planned during the study.
• Subject deprived of freedom through a legal or administrative decision, or in care or under legal guardianship.
• Subject unable to comply with the requirements of the protocol according to the opinion of the investigator.
• Physical or linguistic impairment for signing the informed consent form.
• Current participation planned participation or participation in previous weeks or months in another clinical study that may interfere with the study according to the opinion of the investigator.
• Subject who has participated twice in a clinical study using the Er YAG laser on the forearms.

2. Criteria related to diseases and general health:

• Subject with known immunodeficiency.
• Subject with known acquired immunodeficiency syndrome.
• Subject with known infectious hepatitis or a known history of hepatitis B or C.
• 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 products.
• Subject with a recognized addiction to alcoholism or drug.
• Subject having already presented cicatrization disorders.
• Subject presenting pathology of cicatrization or pathology with consequences on cicatrization such as diabetes.
• 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.
• Subject with a history of atopic eczema on the upper limbs (arms, forearms, hands).
• Subject with skin lesion, solar erythema, tanning marks, scar(s), tattoo(s), significant hair growth, nevus, visible or prominent veins on study areas that may interfere with the interpretation of the evaluation criteria according to the opinion of the investigator.
• Subject presenting hereditary disorders or acquired haemostasis.
• Subject with congenital methemoglobinemia or porphyria.
• Subject with chronic or acute pathology able to interfere with the results of the study according to the opinion of the investigator.

3. Criteria related to treatments

• Diuretic or diuretic systemic treatment initiated or modified in the 2 months prior to the inclusion visit or started at the inclusion visit or whose start is scheduled during the study.
• Treatment liable to induce methemoglobinemia (sulfonamides, dapsone, metoclopramide, flutamide, sodium nitroprusside) in the 14 days prior to the inclusion visit or during the inclusion visit.
• Systemic corticosteroid treatment in the 14 days prior to the inclusion visit or ongoing during the inclusion visit or planned during the study.
• Systemic treatment that may affect haemostasis, including anti-coagulant, antiplatelet therapy, within 7 days prior to the inclusion visit or ongoing at the inclusion visit or planned during the study.
• Systemic treatment with non-steroidal anti-inflammatory drug in the 7 days prior to the inclusion visit or ongoing at the inclusion visit (from 3 days of intake).
• Systemic treatment liable to affect the healing process according to the opinion of the investigator in the weeks prior to the inclusion visit, ongoing at the inclusion visit or planned during the study.
• Systemic or topical antibiotic and/or antifungal treatment within 4 weeks prior to the inclusion visit or ongoing at the inclusion visit.
• Topical antiseptic treatment applied to the upper limbs (including the hands) within 2 weeks prior to the inclusion visit or ongoing at the inclusion visit.
• Topical non-steroidal anti-inflammatory treatment, topical corticosteroids, immunomodulators applied to the upper limbs (including the hands) in the 15 days prior to the inclusion visit or ongoing at the inclusion visit or planned during the study.
• Physical treatment including forearm radiotherapy on the forearm in the 6 months prior to the inclusion visit or ongoing at the inclusion visit or planned during the study.
• Phototherapy treatment on the forearm in the 8 weeks prior to the inclusion visit, ongoing at the inclusion visit or planned during the study.
• Subject with intense and prolonged exposure to UV (natural or artificial) in the forearms in the 2 weeks prior to the inclusion visit or planned during the study.
• Any other treatments taken, applied or modified in the weeks prior to the inclusion visit, ongoing at the inclusion visit or planned during the study that may interfere with the study according to the opinion of the investigator.
• Use of keratolytic, exfoliating or self-tanning products on the upper limbs (including hands) in the 14 days prior to the inclusion visit or on the day of the inclusion visit.
• Use of a skin care product on the upper limbs (including the hands) in the 7 days prior to the inclusion visit or the day of the inclusion visit.
• Application of water, hygiene products on the upper limbs in the 8 hours prior to the inclusion visit, without hygiene usual routine modification during the study.
• Subject having modified his usual body hygiene routine the day before the inclusion visit or planned to modify during the study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer THEUNIS, MD

Role: PRINCIPAL_INVESTIGATOR

SKIN RESEARCH CENTRE - Toulouse

Locations

Skin Research Centre

Toulouse, Haute-Garonne, France

Countries

France

Other Identifiers

RV1551P20220376

Identifier Type: -

Identifier Source: org_study_id