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Evaluation of the Effect of a Lotion on Antidandruff and on Mediating Microbiome Rebalance Versus Vehicle and Reference on Volunteers
Edit Brief Summary: To evaluate the NaP lotion effect to decrease dandruff scoring and microbiome rebalance. Detailed Description: Dandruff is a common scalp disorder affecting almost half of the population of any gender and ethnicity. Skin microflora, in particular Malassezia genus, plays a key etiological role which was demonstrated in many studies. Malassezia restricta was found as the major fungal species present on the scalps with or without dandruff; while the two main bacterial species found on the scalp surface were Propionibacterium acnes and Staphylococcus epidermidis. Dandruff seems correlated with a higher incidence of Malassezia restricta and Staphylococcus epidermidis and a lower incidence of Cutibacterium acnes. Also, the link between dandruff and a higher level of scalp surface lipoperoxidation has been recently described. In fact, dandruff scalp surface is also characterized by higher amounts of squalene monohydroperoxide (SQOOH) and malondialdehyde. MDA is a late biomarker derived from sebaceous unsaturated free fatty acids. Some bibliographic elements suggest that these lipid biomarkers could trigger dandruff. The main objective of that clinical study is to study the effect on dandruff of a leave-on formulation of anti-fungus NaP associated with anti-oxidant VitCG versus vehicle and versus reference leave-on anti-fungus alone Octopirox, all associated with a neutral shampoo.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
Yes
PhD TRIAL
Lisbon, Portugal
Start Date
September 1, 2024
Primary Completion Date
May 2, 2025
Completion Date
June 1, 2025
Last Updated
February 7, 2025
120
ESTIMATED participants
NaP1%+VitCG3% leave-on lotion (formula 1256103)
OTHER
vehicle (formula 1256145)
OTHER
reference Octopirox 0.25% (formula 1256149).
OTHER
Lead Sponsor
L'Oreal
Data Source & Attribution
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