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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tested product RV3438G associated with gentle balancing shampoo |
| ||
| Tested product RV3438G associated with neutral shampoo |
| ||
| Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase 1: short intensive treatment phase | Other | During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed after 8 weeks of use, during the maintenance phase |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed at baseline and after 2, 6 and 10 weeks of use |
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Inclusion Criteria:
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 :
Exclusion Criteria:
Criteria related to the diseases / skin condition:
Criteria related to treatments and/or products:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pascal REYGAGNE, Dr | Centre de santé SABOURAUD - Hôpital Saint Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Santé Sabouraud - Hôpital Saint Louis | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41893958 | Derived | 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. | |
| 41680533 |
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Swab sampling of the scalp and cigarette paper sample on the target lesions
| Phase 2 : Tested product RV3438G associated with gentle balancing shampoo | Other | 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 shampoo | Other | 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 shampoo | Other | During maintenance phase (phase 2): the neutral shampoo RD0057H was applied thrice a week for 8 weeks. |
|
| 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) | 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) | 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) | 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) | 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) | 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) | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | assessed at baseline and after 2, 6 and 10 weeks of use |
| Genies 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. |
| 40498389 | Derived | Maitre 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. |
| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D017443 | Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |
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