NCT06578962|Completed
Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States
Evaluation of the Effects of Shampoo RV3438G in Recurrent Squamous States and Maintenance of the Effects
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Evaluation of the Effects of Shampoo RV3438G in Recurrent Squamous States and Maintenance of the Effects
Sponsor study identifier
observational
63
1 country
1
Study Start
November 9, 2020
Actual (reported)Primary Completion
May 11, 2021
Actual (reported)Study Completion
May 11, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 11, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 9, 2020
Actual (reported)May 11, 2021
Actual (reported)May 11, 2021
Actual (reported)April 30, 2024
Actual (reported)August 30, 2024
Actual (reported)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
Efficacy of the test product RV3438G during the treatment phase by the global evolution of the squamous state assessed by the investigator
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 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 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 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 weekly at home
During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks.
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.
Centre de Santé Sabouraud - Hôpital Saint Louis
Paris, 75010, France
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.
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.
Swab sampling of the scalp and cigarette paper sample on the target lesions
Pascal REYGAGNE, Dr
Centre de santé SABOURAUD - Hôpital Saint Louis
63 participants (actual enrollment reported by the registry).
First Submitted
April 30, 2024
First Posted
August 30, 2024
Study Start
November 9, 2020
Actual (reported)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.
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.
During maintenance phase (phase 2): the neutral shampoo RD0057H was applied thrice a week for 8 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
May 11, 2021
Actual (reported)Study Completion
May 11, 2021
Actual (reported)Last Updated
August 30, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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