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

Pierre Fabre

Status: Terminated

Conditions: Erythrocouperose Associated With Pityriasis Folliculorum of the Face

Treatments: Other: RV5026B - ET1732 - Period 2; Other: RV5026B - ET1732 - Period 1; Drug: reference topical product - Period 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06824870

RV5026B20220514

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Treated group (first hemiface)

Experimental group

Description:

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

Control group (second hemiface)

Other group

Description:

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