CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Phase 1: short intensive treatment phase +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06578962
NCT06578962N/ACompleted

Evaluation of the Effects of Shampoo RV3438G in Recurrent Squamous States and Maintenance of the Effects

Pierre Fabre Dermo Cosmetique·observational·Posted Aug 30, 2024·Updated Aug 30, 2024

In Brief

An observational study evaluating Phase 1: short intensive treatment phase, Phase 2 : Tested product RV3438G associated with gentle balancing shampoo, and 2 other interventions for Dermatitis, Seborrheic. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 30, 2024
Enrollment StartNov 9, 2020
Primary CompletionMay 11, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 1.8 years ago

Interventions

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.