NCT06813521

Antidandruff Lotion Mediating Microbiome Rebalance

Evaluation of the Effect of a Lotion on Antidandruff and on Mediating Microbiome Rebalance Versus Vehicle and Reference on Volunteers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: L'Oreal · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Dandruff

Interventions

Type	Name	Description
OTHER	NaP1%+VitCG3% leave-on lotion (formula 1256103)	leave-on lotion
OTHER	vehicle (formula 1256145)	vehicle lotion
OTHER	reference Octopirox 0.25% (formula 1256149).	lotion reference Octopirox 0.25%

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-05-02
• Completion: 2025-06-01
• First posted: 2025-02-07
• Last updated: 2025-02-07

Locations

1 site across 1 country: Portugal