Antidandruff Lotion Mediating Microbiome Rebalance

NCT06813521 | Recruiting

• 1 other identifier: ACR-PAN1-19-01989
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lotion; antidandruff; microbiome rebalance

Outcome Measures

Primary Outcomes (1)

• Global score of dandruff status of the scalp: evaluation of adherent and non-adherent dandruff according

  scale ranging from 0 (no dandruff) to 5 (maximum score of dandruff adherent and non adherent)

  Day 0 and Day 28

Secondary Outcomes (1)

• Analysis of Malassezia sp, Cutibacterium sp and Staphylococcus sp

  Day 0 and Day 28

Study Arms (3)

NaP1%+VitCG3% leave-on lotion

EXPERIMENTAL

Other: NaP1%+VitCG3% leave-on lotion (formula 1256103)

vehicle

PLACEBO COMPARATOR

Other: vehicle (formula 1256145)

Reference Octopirox 0.25%

ACTIVE COMPARATOR

Other: reference Octopirox 0.25% (formula 1256149).

Interventions

NaP1%+VitCG3% leave-on lotion (formula 1256103) OTHER

leave-on lotion

NaP1%+VitCG3% leave-on lotion

vehicle (formula 1256145) OTHER

vehicle lotion

vehicle

reference Octopirox 0.25% (formula 1256149). OTHER

lotion reference Octopirox 0.25%

Reference Octopirox 0.25%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female volunteer;
• from 18 to 60 years old;
• Skin Phototype (Fitzpatrick): I to IV;
• Subject with hair length \> 2 cm, and preferentially shorter than shoulder length;
• Female of childbearing potential, who is not sexually active, or using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study or menopausal woman (with absence of menstruations for less than one year) or post-menopausal woman (with absence of menstruations for more than one year);
• total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10);
• adherent dandruff score \> or = 2.5 (ranging from 0 to 5);
• no limit for non-adherent dandruff score (ranging from 0 to 5);
• Subject usually using a shampoo 3 times/week and willing to have two to three times/week shampoos during the course of the study;
• Subject agreeing to use only the supplied products during all the study;
• Subjects agreeing to have 1 zone of less than 2x2cm2 on the scalp for non-invasive sample taking (swabs);
• Subject agreeing to have hair shaved on 1 identified zone (1x0.5cm shaved on the high corner of each zone sampling);
• Subject who demonstrate understanding of the study and willingness to participate as evidenced by voluntary written informed consent and have received a signed and dated copy of the informed consent form.
• Subject affiliated to a social security or insurance system;
• Subject willing to comply to the study requirements;

You may not qualify if:

• Edit
• Healthy male or female volunteer;
• from 18 to 60 years old;
• Skin Phototype (Fitzpatrick): I to IV;
• Subject with hair length \> 2 cm, and preferentially shorter than shoulder length;
• Female of childbearing potential, who is not sexually active, or using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study or menopausal woman (with absence of menstruations for less than one year) or post-menopausal woman (with absence of menstruations for more than one year);
• total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10);
• adherent dandruff score \> or = 2.5 (ranging from 0 to 5);
• no limit for non-adherent dandruff score (ranging from 0 to 5);
• Subject usually using a shampoo 3 times/week and willing to have two to three times/week shampoos during the course of the study;
• Subject agreeing to use only the supplied products during all the study;
• Subjects agreeing to have 1 zone of less than 2x2cm2 on the scalp for non-invasive sample taking (swabs);
• Subject agreeing to have hair shaved on 1 identified zone (1x0.5cm shaved on the high corner of each zone sampling);
• Subject who demonstrate understanding of the study and willingness to participate as evidenced by voluntary written informed consent and have received a signed and dated copy of the informed consent form.
• Subject affiliated to a social security or insurance system;

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

PhD TRIAL

Lisbon, 1750-18, Portugal

RECRUITING

MeSH Terms

Conditions

Dandruff

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Scalp Dermatoses

Central Study Contacts

AUDREY GABY GUENICHE, PharmaD and phD

CONTACT

+33660992467; audrey.gueniche@loreal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: cosmetic product

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: February 7, 2025
• Study Start: September 1, 2024
• Primary Completion: May 2, 2025
• Study Completion: June 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

PT (1)