Clinical trial NCT06824870: Exploratory Study Evaluating the Effects of Dermo-cosmetic RV5026B Applied for 2 Months in Adults With Erythrocouperosis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Erythrocouperose Associated With Pityriasis Folliculorum of the Face
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2025-02-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Erythema score
timeFrame: Day 1, Day 29 & Day 57
measure: Overall dynamic efficiency score
timeFrame: Day 29 & Day 57
measure: Demodex density
timeFrame: Day 1, Day 29 & Day 57
measure: Rating of the intensity of the erythema
timeFrame: Day 1, Day 29 & Day 57
measure: Flush score
timeFrame: Day 1, Day 29 & Day 57
measure: Dynamic SGA (subject global assessment) scale
timeFrame: Day 1, Day 29 & Day 57
measure: Subject acceptability questionnaire
timeFrame: Day 29 & Day 57
measure: Tolerance of the products for 2 months of use by adverse events
timeFrame: Day 1, Day 29 & Day 57
measure: Tolerance of the tested product for 2 months of use by global tolerance per subject
timeFrame: Day 29 & Day 57
measure: Subject's compliance regarding the test product
timeFrame: During the entire course of the study (approximately 57 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Schaerbeek
country: Belgium
facility: Dr FORTON
Study officials:
References: