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

Exploratory Study Evaluating the Effects of RV5026B Dermo-cosmetic Treatment ET1732 Formula Applied for 2 Months in Adult Subjects With Erythrocouperosis Associated With Pityriasis Folliculorum.

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

Study Overview

• Status: Terminated
• Conditions: Erythrocouperose Associated With Pityriasis Folliculorum of the Face
• Intervention / Treatment: Other: RV5026B - ET1732 - Period 1; Drug: reference topical product - Period 2; Other: RV5026B - ET1732 - Period 2

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Schaerbeek, Belgium, 1030
    • Dr FORTON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main 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

Main non-inclusion criteria:

- 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated group (first hemiface); Treated group = hemi-face with the reference topical product and the tested product RV5026B - ET1732 during period 2	Other: 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.; Drug: 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.; Other: 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.
Other: Control group (second hemiface); Control group = hemi-face with the reference topical product alone during period 2	Other: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema score	Assessed by the investigator according to the Investigator Global Assessment - IGA - scale (score from 0 to 3: None toSevere) on each side of the face	Day 1, Day 29 & Day 57
Overall dynamic efficiency score	Assessed by the investigator according to Investigator's Global Assessment (IGA) - (-3 to +3) (Very significant worsening = -3to Very significant improvement = +3) compared with baseline status at visit 1 on each side of the face	Day 29 & Day 57
Demodex density	assessed by Standardized Skin Surface Biopsy (SSSB1 & SSSB2 and SSSB1+2) on each hemiface by on-site optical microscope count, then protein analysis on SSSBs sample	Day 1, Day 29 & Day 57
Rating of the intensity of the erythema	(score from 0 to 100) by centralized a posteriori analysis of the photographs taken on each side of the face, carried out by an expert dermatologist using software presenting the images taken for each of the subjects, blindly	Day 1, Day 29 & Day 57
Flush score	Score over the last 3 days preceding the assessment according to the Global Flushing Severity Score - GFSS - numerical scale (score from 0 to 10 - None to Extreme: ) on each side of the face	Day 1, Day 29 & Day 57
Dynamic SGA (subject global assessment) scale	Scale with 7 points (-3 to +3) (Very significant worsening = -3 to Very significant improvement = +3) in comparison with the initial state of visit 1 on each side	Day 1, Day 29 & Day 57
Subject acceptability questionnaire	assessed by the subject with subject's questionnaire	Day 29 & Day 57
Tolerance of the products for 2 months of use by adverse events	Recording of Adverse events	Day 1, Day 29 & Day 57
Tolerance of the tested product for 2 months of use by global tolerance per subject	assessed by the investigator for both groups and per subject, considering all individual AE and their characteristics, based on a 5-point scale (0=Bad tolerance, 4= Excellent tolerance)	Day 29 & Day 57
Subject's compliance regarding the test product	The subject will report his compliance in a subject's diary.	During the entire course of the study (approximately 57 days)

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Pityriasis
• Other Study ID Numbers: RV5026B20220514

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No