NCT06578962

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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, 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

Conditions

• Dermatitis, Seborrheic

Interventions

Type	Name	Description
OTHER	Phase 1: short intensive treatment phase	During the treatment phase (phase 1), all subjects of the study applied the tested product RV3438G, thrice a week, for 2 weeks.
OTHER	Phase 2 : Tested product RV3438G associated with gentle balancing shampoo	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.
OTHER	Phase 2 : Tested product RV3438G associated with neutral shampoo	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.
OTHER	Phase 2 : neutral shampoo	During maintenance phase (phase 2): the neutral shampoo RD0057H was applied thrice a week for 8 weeks.

Timeline

• Start date: 2020-11-09
• Primary completion: 2021-05-11
• Completion: 2021-05-11
• First posted: 2024-08-30
• Last updated: 2024-08-30

Locations

1 site across 1 country: France