Antidandruff Lotion Mediating Microbiome Rebalance

Recruiting now · Not applicable

Conditions studied: Dandruff

In brief

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.

Key facts

Study ID

NCT06813521

Run by

L'Oreal

People needed

120

Starts

2024-09-01

Expected to finish

2025-06-01

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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);
• Subject exhibiting moderate to severe dandruff status of scalp at screening, pre-inclusion and inclusion visit;
• Subject having at inclusion visit Day 0:
• 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;
• Subject who is willing not to take part in another clinical study in another investigating center;
• Subject who agree to give accurate personal in personal information;
• Subject who are able to attend all study visits. * The effective contraceptive methods: sexually active female of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal device, intrauterine device (IUD), condom with spermicide.

You may not qualify if…

• Edit
• Eligibility Criteria: Inclusions criterias:
• 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);
• Subject exhibiting moderate to severe dandruff status of scalp at screening, pre-inclusion and inclusion visit;
• Subject having at inclusion visit Day 0:
• 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;
• Subject who is willing not to take part in another clinical study in another investigating center;
• Subject who agree to give accurate personal in personal information;
• Subject who are able to attend all study visits. * The effective contraceptive methods: sexually active female of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal device, intrauterine device (IUD), condom with spermicide.
• Non-inclusion criterias:
• Subject with any systemic disorder or skin or scalp disease that would, in the investigator's judgment, significantly affect the interpretation of the study results (e.g. seborrheic dermatitis which shows the syndrome of invasion plaque and/or pityriasis amiantacea, atopic dermatitis, eczema or psoriasis);
• Female subject who is known to be pregnant or who is intending to become pregnant over the duration of the study;

Where it is running

• PhD TRIAL — Lisbon, Portugal (enrolling)

Full record on ClinicalTrials.gov

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