Exploratory Study Evaluating the Effects of Dermo-cosmetic RV5026B Applied for 2 Months in Adults With Erythrocouperosis

NCT ID: NCT06824870

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2025-02-20

Brief Summary

This exploratory study aims to evaluate the effects of the test product RV5026B - ET1732 on erythema, as well as on the sensations of discomfort and relief perceived in subjects with erythrocouperose and associated pityriasis folliculorum.

We wish to evaluate:

• firstly the test product alone in order to quantify the effects on the signs & symptoms on the entire face,
• then the contribution of the test product in addition to a reference topical treatment.

The test product RV5026B - ET1732 was developed to:

• Reduce redness, even if it has already set in, and help limit its reappearance
• Soothe the sensations of heating and discomfort associated

Conditions

Erythrocouperose Associated With Pityriasis Folliculorum of the Face

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treated group (first hemiface)

Treated group = hemi-face with the reference topical product and the tested product RV5026B - ET1732 during period 2

Group Type: EXPERIMENTAL

No interventions assigned to this group

Control group (second hemiface)

Control group = hemi-face with the reference topical product alone during period 2

Group Type: OTHER

No interventions assigned to this group

Interventions

RV5026B - ET1732 - Period 1

Period 1 (1 month): The tested product RV5026B - ET1732 will be applied twice a-day on full-face The product sould be applied in sufficient quantity to cover the application area.

Intervention Type: OTHER

reference topical product - Period 2

Period 2 (1 month) : the reference topical product, prescribed by the investigator will applied each evening on the whole face.

Intervention Type: DRUG

RV5026B - ET1732 - Period 2

Period 2 (1 month) : The tested product RV5026B - ET1732 will be applied twice a-day on randomised half-face. The evening application will be done 15 minutes after the application of the reference treatment. Hands must be washed between the application of the 2 products.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Man or woman aged 18 to 75 years old
• Subject presenting erythrocouperosis associated with pityriasis folliculorum of the face with erythema of mild to severe intensity according to the IGA clinical rating on both cheeks
• High density of Demodex on both cheeks: SSSB1 > 5 D/cm² or SSSB2 > 10 D/cm²

• Subject presenting, on the day of inclusion, a dermatological condition of the face other than that studied

1. ORAL/GENERAL TREATMENTS that were planned to be taken during the study OR that were taken:

A. In the last 3 months:

• Any change in hormone replacement therapy.

• Any oral treatment Vit A or derivatives

B. In the last 4 weeks:

• Any change in oral drug treatment that could modify the skin characteristics of the subjects and interfere with the performance of the study product

• Tetracyclines

• Immunosuppressant

• Antiparasitic

• Corticosteroid or NSAID taken for more than 5 consecutive days

C. In the last 2 weeks:

• Antibiotic with known cutaneous impact

2. LOCAL TREATMENTS that were planned to be taken during the study OR that were taken:

A. In the last 3 months:

• Vascular laser of the face

B. In the last 4 weeks:

• Any topical medicinal product on the face that could modify the skin characteristics of the subjects and interfere with the performance of the study product.

C. In the last 10 days:

• Changes to any topical cosmetic product (toiletries, care products and makeup) on the face

D. In the last 7 days:

• Topical antiseptic on the face
• Any topical cosmetic product applied to the face that could modify the skin characteristics of the subjects and interfere with the performance of the product under study

E. Since the last wash performed the night before:

• Application of topical treatment, rinsed or non-rinsed dermocosmetic product on the face

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr FORTON

Schaarbeek, , Belgium

Countries

Belgium

Other Identifiers

RV5026B20220514

Identifier Type: -

Identifier Source: org_study_id