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

NCT06824870 | Terminated

• 1 other identifier: RV5026B20220514
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 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)

Study Arms (2)

Treated group (first hemiface)

EXPERIMENTAL

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

Control group (second hemiface)

OTHER

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

Interventions

RV5026B - ET1732 - Period 1 OTHER

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.

reference topical product - Period 2 DRUG

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

RV5026B - ET1732 - Period 2 OTHER

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Dr FORTON

Schaarbeek, 1030, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: During the first period, the tested product will be applied to the entire face. At Visit 2, after investigator assessments, the subjects will stop the study if they don't need a treatment by reference topical product. If they need it, they will continue the study and will apply: * the reference topical product, prescribed by the investigator on the entire face * the tested product on a single half-face according to randomization.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: October 20, 2023
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

BE (1)