Dermatitis, SeborrheicNCT06578962
Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States
An observational study of Dermatitis, Seborrheic, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
The aim of the study is to evaluate, with clinical, biological and biometrological assessment methods, the effectiveness of RV3438G shampoo, after 2 weeks of short intensive treatment phase and also the effects of a maintenance phase of 8 weeks in association with a neutral shampoo, or with a gentle balancing shampoo… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dermatitis, Seborrheic
- What is being tested?
- Phase 1: short intensive treatment phase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2020to 11 May 2021
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects will be recruited from the panel of volunteers of the centre. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.
Who may be able to join
- Criteria related to the population:
- Subject aged between 18 and 60 years included
- Criteria related to the disease:
- Subject having a squamous state of the scalp :
- clinically visible (Squire score ≥ 20),
- with an intensity of the squamous state superior or equal to 2 on a scale from 0 to 3 on at - least 1 of the 4 scalp areas
- recurrent (at least twice a year)
- associated to erythema and pruritus: erythema scoring superior or equal to 1 on a scale from 0 to 3 on at least 1 scalp area desquamating of the 4 scalp areas pruritus scoring assessed by the subject superior or equal to 3 on a numerical scale from 0 to 10 (mean pruritus felt on the last 3 days)
Who cannot join
- Criteria related to the diseases / skin condition:
- Subject having frizzy hair
- Subject with an alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis), Seborrheic dermatitis requiring medical treatment
- Criteria related to treatments and/or products:
- Systemic treatment with nonsteroidal anti-inflammatory, corticosteroid, antibiotic, antihistamine taken during 5 consecutive days within the 2 weeks before the inclusion or planned during the study and liable to interfere with the study assessments
- Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
- Any scalp dyeing, bleaching, perm, smoothing / straightening performed within 2 weeks before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Shampoo RV3438G in Recurrent Squamous States and Maintenance of the Effects
The aim of the study is to evaluate, with clinical, biological and biometrological assessment methods, the effectiveness of RV3438G shampoo, after 2 weeks of short intensive treatment phase and also the effects of a maintenance phase of 8 weeks in association with a neutral shampoo, or with a gentle balancing shampoo, compared to a neutral shampoo used single.
This is a bicentric, comparative (during the maintenance phase), randomized, controlled and open study, in parallel groups conducted in subjects having mild to moderate recurrent squamous states, for 10 weeks.
Read more
4 visits are planned. The maximum duration of the study is 74 days from inclusion visit to the End-of-study visit.
The study area is the whole scalp.
Read the detailed description
4 visits are performed: Visit 1: Inclusion (Day1) : start of the short intensive treatment phase (phase 1) Visit 2: Intermediate visit (Day15 ± 3 days, Week 2) : end of the short treatment intensive phase and start of the maintenance phase (phase 2) Visit 3: Intermediate visit (Day 43 ± 3 days, Week 6) : middle of the maintenance phase Visit 4: End-of-study visit (Day 71 ± 3 days, Week 10) : end of the maintenance phase
- Conditions
- Dermatitis, Seborrheic
- Being tested
- Phase 1: short intensive treatment phase, Phase 2 : Tested product RV3438G associated with gentle balancing shampoo, Phase 2 : Tested product RV3438G associated with neutral shampoo, Phase 2 : neutral shampoo
- Keywords
- Dermatitis, Seborrheic, Scalp, Adults, Maintenance of effects
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1: short intensive treatment phaseOther
During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks.
Phase 2 : Tested product RV3438G associated with gentle balancing shampooOther
During maintenance phase (phase 2):
the tested product RV3438G was applied once a week for 8 weeks the gentle balancing shampoo RD1089O was applied twice a week alternately with the RV3438G shampoo, for 8 weeks.
Phase 2 : Tested product RV3438G associated with neutral shampooOther
During maintenance phase (phase 2):
the tested product RV3438G was applied once a week for 8 weeks the neutral shampoo RD0057H was applied twice a week alternately with the RV3438G shampoo, for 8 weeks.
Phase 2 : neutral shampooOther
During maintenance phase (phase 2):
the neutral shampoo RD0057H was applied thrice a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tested product RV3438G associated with gentle balancing shampoo | Not described Receives: Other: Phase 1: short intensive treatment phase; Other: Phase 2 : Tested product RV3438G associated with gentle balancing shampoo | |
| Tested product RV3438G associated with neutral shampoo | Not described Receives: Other: Phase 1: short intensive treatment phase; Other: Phase 2 : Tested product RV3438G associated with neutral shampoo | |
| Control group | Not described Receives: Other: Phase 1: short intensive treatment phase; Other: Phase 2 : neutral shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the test product RV3438G during the maintenance phase by the global evolution of the squamous state assessed by the investigator
Dandruff score, from 0 to 80, calculated by the investigator with intensity (= severity, score from 1 to 5) x extent (= area, score from 0 to 4), for each quadrant of the scalp
Measured: Assessed after 8 weeks of use, during the maintenance phase
Secondary outcomes (16)
Efficacy of the test product RV3438G during the treatment phase by the global evolution of the squamous state assessed by the investigator
Dandruff score, from 0 to 80, calculated by the investigator with intensity (= severity, score from 1 to 5) x extent (= area, score from 0 to 4), for each quadrant of the scalp
Measured: Assessed at baseline and after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the erythema evolution of the squamous state assessed by the investigator
assessed by the investigator on the scalp on a 4-point scale (from absent to severe)
Measured: assessed at baseline and after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the pruritus evolution of the squamous state assessed by the subject
assessed by the subject on the scalp on a 10-point scale (from absent to maximal severity)
Measured: assessed at baseline and after 2, 6 and 10 weeks of use and weekly at home
Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the investigator
assessed by the investigator on the scalp on a 5-point scale (from worsening to complete resolution)
Measured: assessed after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the subject
assessed by the subject on the scalp on a 5-point scale (from worsening to complete resolution)
Measured: assessed weekly at home
Efficacy of the test product RV3438G by the evolution of the squamous state assessed by the subject
assessed by the subject on the scalp on a 4-point scale (from absent to severe)
Measured: assessed at baseline and after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the evolution of the scalp discomfort assessed by the subject
assessed by the subject on the scalp on a 4-point scale (from absent to severe)
Measured: assessed at baseline and weekly at home
Efficacy of the test product RV3438G by the analysis of skin microbiota diversity from scalp swab samples
Microbiota diversity is analyzed by 16S and ITS1 sequencing.
Measured: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of skin microbiota composition from scalp swab samples
Microbiota composition is analyzed by ddPCR of some fungal and bacterial species
Measured: assessed at baseline and after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of Inflammatory marker evolution from scalp swab samples
Measured: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of prurit marker evolution from scalp swab samples
Measured: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of cellular cohesion proteins evolution from scalp swab samples
Measured: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the Metabolomic analysis from scalp swab samples
Measured: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of molecular profiles of lipids from scalp cigarette paper sample
Assessed by FTIR analysis
Measured: assessed at baseline and after 2, 6 and 10 weeks of use
Compliance of the subjects to the test product RV3438G
The subject will report his/her compliance in a subject's diary
Measured: through study completion, 10 weeks
Tolerance of the test product RV3438G assessed by the investigator
Determined by the subject's spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
Measured: assessed at baseline and after 2, 6 and 10 weeks of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start9 Nov 2020
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, SeborrheicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal REYGAGNE, Dr, Principal investigator, Centre de santé SABOURAUD - Hôpital Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578962
- Sponsor's protocol ID
- RV3438G2020043
- Status last verified
- Aug 2024
- First submitted
- 30 Apr 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Darras L, Ipinazar C, Gravier E, Mercadie A, Villaret A, Marinescu R, Maitre M, Genies C, Mengeaud V, Fournier I, Josse G. Lipidomic Insights into Seborrheic Dermatitis: Clinical Evaluation of Sebum Changes Using SpiderMass. Dermatol Ther (Heidelb). 2026 May;16(5):2465-2481. doi: 10.1007/s13555-026-01719-9. Epub 2026 Mar 27.
PubMed 41893958Genies C, Maitre M, Baradat S, Froliger M, Turlier V, Mercadie A, Simcic-Mori A, Gravier E, Lauze C, Huyghe C, Alvarez-Georges S, Chansard N, Marinescu R, Reygagne P, Bessou-Touya S, Mengeaud V, Duplan H. Metabolomics in Scalp Seborrheic Dermatitis Evidenced Key Changes in Inflammatory Markers Following a 10-Week Scalp Care Scheme with an Anti-dandruff Shampoo. Dermatol Ther (Heidelb). 2026 Mar;16(3):1647-1664. doi: 10.1007/s13555-026-01658-5. Epub 2026 Feb 13.
PubMed 41680533Maitre M, Baradat S, Froliger M, Turlier V, Simcic-Mori A, Gravier E, Genies C, Lauze C, Huyghe C, Noustens A, Alvarez-Georges S, Marinescu R, Reygagne P, Bessou-Touya S, Mengeaud V, Duplan H. Scalp Microbiome Dynamics Can Contribute to the Clinical Effect of a Novel Antiseborrheic Dermatitis Shampoo Containing Patented Antifungal Actives: A Randomized Controlled Study. Dermatol Ther (Heidelb). 2025 Aug;15(8):2077-2097. doi: 10.1007/s13555-025-01408-z. Epub 2025 Jun 11.
PubMed 40498389
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Shampoo RV3438G in Recurrent Squamous States and Maintenance of the Effects
- ClinicalTrials.gov ID
- NCT06578962
- Acronym / sponsor ID
- RV3438G2020043
- Conditions
- Dermatitis, Seborrheic
- Keywords
- Dermatitis, Seborrheic, Scalp, Adults, Maintenance of effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 30 Aug 2024 (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.
The aim of the study is to evaluate, with clinical, biological and biometrological assessment methods, the effectiveness of RV3438G shampoo, after 2 weeks of short intensive treatment phase and also the effects of a maintenance phase of 8 weeks in association with a neutral shampoo, or with a gentle balancing shampoo, compared to a neutral shampoo used single.
This is a bicentric, comparative (during the maintenance phase), randomized, controlled and open study, in parallel groups conducted in subjects having mild to moderate recurrent squamous states, for 10 weeks.
4 visits are planned. The maximum duration of the study is 74 days from inclusion visit to the End-of-study visit.
The study area is the whole scalp.
Detailed description
4 visits are performed: Visit 1: Inclusion (Day1) : start of the short intensive treatment phase (phase 1) Visit 2: Intermediate visit (Day15 ± 3 days, Week 2) : end of the short treatment intensive phase and start of the maintenance phase (phase 2) Visit 3: Intermediate visit (Day 43 ± 3 days, Week 6) : middle of the maintenance phase Visit 4: End-of-study visit (Day 71 ± 3 days, Week 10) : end of the maintenance phase
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tested product RV3438G associated with gentle balancing shampoo | – | Other: Phase 1: short intensive treatment phase, Other: Phase 2 : Tested product RV3438G associated with gentle balancing shampoo |
| Tested product RV3438G associated with neutral shampoo | – | Other: Phase 1: short intensive treatment phase, Other: Phase 2 : Tested product RV3438G associated with neutral shampoo |
| Control group | – | Other: Phase 1: short intensive treatment phase, Other: Phase 2 : neutral shampoo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited from the panel of volunteers of the centre. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.
Key inclusion criteria (8 listed)
- Subject aged between 18 and 60 years included
- clinically visible (Squire score ≥ 20),
- with an intensity of the squamous state superior or equal to 2 on a scale from 0 to 3 on at - least 1 of the 4 scalp areas
- recurrent (at least twice a year)
- associated to erythema and pruritus: erythema scoring superior or equal to 1 on a scale from 0 to 3 on at least 1 scalp area desquamating of the 4 scalp areas pruritus scoring assessed by the subject superior or equal to 3 on a numerical scale from 0 to 10 (mean pruritus felt on the last 3 days)
Key exclusion criteria (7 listed)
- Subject having frizzy hair
- Subject with an alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis), Seborrheic dermatitis requiring medical treatment
- Systemic treatment with nonsteroidal anti-inflammatory, corticosteroid, antibiotic, antihistamine taken during 5 consecutive days within the 2 weeks before the inclusion or planned during the study and liable to interfere with the study assessments
- Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
- Any scalp dyeing, bleaching, perm, smoothing / straightening performed within 2 weeks before inclusion
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 |
|---|---|---|
| Phase 1: short intensive treatment phaseDuring the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks. | Other | Control group, Tested product RV3438G associated with gentle balancing shampoo, Tested product RV3438G associated with neutral shampoo |
| Phase 2 : Tested product RV3438G associated with gentle balancing shampooDuring maintenance phase (phase 2): the tested product RV3438G was applied once a week for 8 weeks the gentle balancing shampoo RD1089O was applied twice a week alternately with the RV3438G shampoo, for 8 weeks. | Other | Tested product RV3438G associated with gentle balancing shampoo |
| Phase 2 : Tested product RV3438G associated with neutral shampooDuring maintenance phase (phase 2): the tested product RV3438G was applied once a week for 8 weeks the neutral shampoo RD0057H was applied twice a week alternately with the RV3438G shampoo, for 8 weeks. | Other | Tested product RV3438G associated with neutral shampoo |
| Phase 2 : neutral shampooDuring maintenance phase (phase 2): the neutral shampoo RD0057H was applied thrice a week for 8 weeks. | Other | Control group |
Primary outcome
Efficacy of the test product RV3438G during the maintenance phase by the global evolution of the squamous state assessed by the investigator
Time frame: Assessed after 8 weeks of use, during the maintenance phase
Dandruff score, from 0 to 80, calculated by the investigator with intensity (= severity, score from 1 to 5) x extent (= area, score from 0 to 4), for each quadrant of the scalp
16 secondary outcomes
Efficacy of the test product RV3438G during the treatment phase by the global evolution of the squamous state assessed by the investigator
Time frame: Assessed at baseline and after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the erythema evolution of the squamous state assessed by the investigator
Time frame: assessed at baseline and after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the pruritus evolution of the squamous state assessed by the subject
Time frame: assessed at baseline and after 2, 6 and 10 weeks of use and weekly at home
Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the investigator
Time frame: assessed after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the global evolution of the squamous state assessed by the subject
Time frame: assessed weekly at home
Efficacy of the test product RV3438G by the evolution of the squamous state assessed by the subject
Time frame: assessed at baseline and after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the evolution of the scalp discomfort assessed by the subject
Time frame: assessed at baseline and weekly at home
Efficacy of the test product RV3438G by the analysis of skin microbiota diversity from scalp swab samples
Time frame: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of skin microbiota composition from scalp swab samples
Time frame: assessed at baseline and after 2, 6 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of Inflammatory marker evolution from scalp swab samples
Time frame: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of prurit marker evolution from scalp swab samples
Time frame: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of cellular cohesion proteins evolution from scalp swab samples
Time frame: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the Metabolomic analysis from scalp swab samples
Time frame: assessed at baseline and after 2 and 10 weeks of use
Efficacy of the test product RV3438G by the analysis of molecular profiles of lipids from scalp cigarette paper sample
Time frame: assessed at baseline and after 2, 6 and 10 weeks of use
Compliance of the subjects to the test product RV3438G
Time frame: through study completion, 10 weeks
Tolerance of the test product RV3438G assessed by the investigator
Time frame: assessed at baseline and after 2, 6 and 10 weeks of use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Derived from this study: PubMed 41893958Darras L, Ipinazar C, Gravier E, Mercadie A, Villaret A, Marinescu R, Maitre M, Genies C, Mengeaud V, Fournier I, Josse G. Lipidomic Insights into Seborrheic Dermatitis: Clinical Evaluation of Sebum Changes Using SpiderMass. Dermatol Ther (Heidelb). 2026 May;16(5):2465-2481. doi: 10.1007/s13555-026-01719-9. Epub 2026 Mar 27.
- Derived from this study: PubMed 41680533Genies C, Maitre M, Baradat S, Froliger M, Turlier V, Mercadie A, Simcic-Mori A, Gravier E, Lauze C, Huyghe C, Alvarez-Georges S, Chansard N, Marinescu R, Reygagne P, Bessou-Touya S, Mengeaud V, Duplan H. Metabolomics in Scalp Seborrheic Dermatitis Evidenced Key Changes in Inflammatory Markers Following a 10-Week Scalp Care Scheme with an Anti-dandruff Shampoo. Dermatol Ther (Heidelb). 2026 Mar;16(3):1647-1664. doi: 10.1007/s13555-026-01658-5. Epub 2026 Feb 13.
- Derived from this study: PubMed 40498389Maitre M, Baradat S, Froliger M, Turlier V, Simcic-Mori A, Gravier E, Genies C, Lauze C, Huyghe C, Noustens A, Alvarez-Georges S, Marinescu R, Reygagne P, Bessou-Touya S, Mengeaud V, Duplan H. Scalp Microbiome Dynamics Can Contribute to the Clinical Effect of a Novel Antiseborrheic Dermatitis Shampoo Containing Patented Antifungal Actives: A Randomized Controlled Study. Dermatol Ther (Heidelb). 2025 Aug;15(8):2077-2097. doi: 10.1007/s13555-025-01408-z. Epub 2025 Jun 11.
- Individual participant dataSharing planned: No
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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.
Pascal REYGAGNE, Dr principal investigator
Centre de santé SABOURAUD - Hôpital Saint Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis, Seborrheic, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 30 Aug 2024. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of the test product RV3438G during the maintenance phase by the global evolution of the squamous state assessed by the investigator (time frame: Assessed after 8 weeks of use, during the maintenance phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06578962, which also lists 3 linked publications.
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 30 Aug 2024.