Actively Recruiting
Antidandruff Lotion Mediating Microbiome Rebalance
Led by L'Oreal · Updated on 2025-02-07
120
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Antidandruff Lotion Mediating Microbiome Rebalance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female volunteers aged 18 to 60 years
- Skin phototype I to IV according to Fitzpatrick scale
- Hair length greater than 2 cm, preferably shorter than shoulder length
- Females of childbearing potential must be not sexually active or use effective contraception, or be menopausal or post-menopausal
- Moderate to severe dandruff on the scalp at screening and inclusion visits
- At inclusion, total dandruff score (adherent + non-adherent) at least 4.5 (scale 0-10)
- At inclusion, adherent dandruff score at least 2.5 (scale 0-5)
- No limit on non-adherent dandruff score
- Regular use of shampoo about three times per week and willing to maintain this during the study
- Agreeing to use only study products during the trial
- Agree to allow a small scalp area (less than 2x2 cm) for non-invasive sample collection
- Agree to have hair shaved on a small scalp area (1x0.5 cm) for sampling
- Understanding and willingness to participate with signed informed consent
- Affiliated with a social security or insurance system
- Willing to comply with study requirements and attend all visits
- Willing not to participate in another clinical study at a different center during this study
- Agree to provide accurate personal information
You will not qualify if you...
- Having any systemic disorder or scalp/skin disease that could affect study results (e.g., seborrheic dermatitis, atopic dermatitis, eczema, psoriasis)
- Pregnant or intending to become pregnant during the study
- Currently breastfeeding or breastfed in the past 6 months
- Male with alopecia grade V or higher; female with alopecia grades I to III
- Having frizzy hair or significant white hair affecting dandruff scoring
- Scalp skin marks interfering with assessments (e.g., pigmentation, tattoos, scars)
- Use of scalp products like dyeing, bleaching, perming, or straightening within 3 weeks before the study
- Use of anti-dandruff treatments within 3 weeks before the study
- Use of cosmetic anti-hair loss treatments within 3 months or medical anti-hair loss treatments within 6 months before the study
- History of allergy or sensitivity to anti-dandruff or cosmetic products containing surfactants or latex
- Use of systemic or prolonged topical corticosteroids, antifungals, antibiotics, anti-inflammatory, or antihistamine drugs within 1 month before the study
- Use of retinoic acid within 3 months before the study
- Receiving medications that may affect study validity or participant wellbeing as judged by investigator
- History or planned medical or surgical events affecting study validity or wellbeing
- Immunosuppressed individuals
- History of skin cancer
- Started, stopped, or changed hormonal treatments including contraceptives within 1 month before the study
- Regular practice of water sports or sauna sessions
- Excessive sun or UV exposure in the month before the study
- Being deprived of liberty by legal decision
- Participation in another clinical study with an ongoing exclusion period
- Unable to be contacted by phone
- Staff member of the investigating center
AI-Screening
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Trial Site Locations
Total: 1 location
1
PhD TRIAL
Lisbon, Portugal, 1750-18
Actively Recruiting
Research Team
A
AUDREY GABY GUENICHE, PharmaD and phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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