Erythrocouperose Associated With Pityriasis Folliculorum of the FaceNCT06824870
Exploratory Study Evaluating the Effects of Dermo-cosmetic RV5026B Applied for 2 Months in Adults With Erythrocouperosis
A study testing RV5026B - ET1732 - Period 1, reference topical product - Period 2 and RV5026B - ET1732 - Period 2 in people with Erythrocouperose Associated With Pityriasis Folliculorum of the Face, run by Pierre Fabre Dermo Cosmetique at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Erythrocouperose Associated With Pityriasis Folliculorum of the Face
- What is being tested?
- RV5026B - ET1732 - Period 1, reference topical product - Period 2 and RV5026B - ET1732 - Period 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2023to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
- ORAL/GENERAL TREATMENTS that were planned to be taken during the study OR that were taken:
- In the last 3 months:
- Any change in hormone replacement therapy.
- Any oral treatment Vit A or derivatives
- 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
- In the last 2 weeks:
- Antibiotic with known cutaneous impact
- LOCAL TREATMENTS that were planned to be taken during the study OR that were taken:
- In the last 3 months:
- Vascular laser of the face
- 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.
- In the last 10 days:
- Changes to any topical cosmetic product (toiletries, care products and makeup) on the face
- 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
- Since the last wash performed the night before:
- Application of topical treatment, rinsed or non-rinsed dermocosmetic product on the face
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- RV5026B - ET1732 - Period 1, reference topical product - Period 2, RV5026B - ET1732 - Period 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV5026B - ET1732 - Period 1Other
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 2Drug
Period 2 (1 month) : the reference topical product, prescribed by the investigator will applied each evening on the whole face.
RV5026B - ET1732 - Period 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1, Day 29 & Day 57
Subject acceptability questionnaire
assessed by the subject with subject's questionnaire
Measured: Day 29 & Day 57
Tolerance of the products for 2 months of use by adverse events
Recording of Adverse events
Measured: 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)
Measured: Day 29 & Day 57
Subject's compliance regarding the test product
The subject will report his compliance in a subject's diary.
Measured: During the entire course of the study (approximately 57 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start20 Oct 2023
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythrocouperose Associated With Pityriasis Folliculorum of the FaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824870
- Sponsor's protocol ID
- RV5026B20220514
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06824870
- Acronym / sponsor ID
- RV5026B20220514
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV5026B - ET1732 - Period 1Period 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. | Other | – |
| reference topical product - Period 2Period 2 (1 month) : the reference topical product, prescribed by the investigator will applied each evening on the whole face. | Drug | – |
| RV5026B - ET1732 - Period 2Period 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 | – |
Primary outcome
Erythema score
Time frame: Day 1, Day 29 & Day 57
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
Overall dynamic efficiency score
Time frame: Day 29 & Day 57
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
Demodex density
Time frame: Day 1, Day 29 & Day 57
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
Rating of the intensity of the erythema
Time frame: Day 1, Day 29 & Day 57
(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
Flush score
Time frame: Day 1, Day 29 & Day 57
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
Dynamic SGA (subject global assessment) scale
Time frame: Day 1, Day 29 & Day 57
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
Subject acceptability questionnaire
Time frame: Day 29 & Day 57
assessed by the subject with subject's questionnaire
Tolerance of the products for 2 months of use by adverse events
Time frame: Day 1, Day 29 & Day 57
Recording of Adverse events
Tolerance of the tested product for 2 months of use by global tolerance per subject
Time frame: Day 29 & Day 57
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)
Subject's compliance regarding the test product
Time frame: During the entire course of the study (approximately 57 days)
The subject will report his compliance in a subject's diary.
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV5026B - ET1732 - Period 1, reference topical product - Period 2 and RV5026B - ET1732 - Period 2 in people with Erythrocouperose Associated With Pityriasis Folliculorum of the Face, run by Pierre Fabre Dermo Cosmetique at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema score (time frame: Day 1, Day 29 & Day 57). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.