Actively Recruiting
Evaluation of the Effect of a Lotion on Antidandruff and Microbiome Rebalance Versus Vehicle and Reference in Volunteers
Led by L'Oreal · Updated on 2025-02-07
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dandruff is a common scalp condition affecting people of all genders and ethnicities, linked to imbalances in the skin's microflora, especially involving the Malassezia genus, Propionibacterium acnes, and Staphylococcus epidermidis. This trial investigates the effects of an anti-fungal lotion containing NaP and antioxidant VitCG on reducing dandruff and rebalancing the scalp microbiome, comparing it to a vehicle lotion and a reference anti-fungal lotion with Octopirox. The study is sponsored by L'Oreal and aims to understand how these treatments impact scalp health at a microbiological level. Participants will be randomly assigned to one of three groups receiving either the experimental NaP1%+VitCG3% leave-on lotion, a vehicle lotion, or a reference Octopirox 0.25% lotion, all used with a neutral shampoo. The treatments are applied as leave-on lotions, and the study evaluates their effects over a 28-day period. The trial includes detailed scalp evaluations and sample collections to analyze changes in dandruff severity and microbial populations. Volunteers aged 18 to 60 with moderate to severe dandruff will attend study visits for assessments on day 0 and day 28, where dandruff scores and microbiome samples will be taken. Participants will have specific scalp zones sampled and shaved for analysis. Researchers will measure dandruff severity and microbial species changes, monitor safety, and ensure adherence by providing all study products and requiring consistent shampoo use during the study. The total participation duration is 28 days, with evaluations focusing on dandruff status and microbiome balance.
CONDITIONS
Brief Title
Antidandruff Lotion Mediating Microbiome Rebalance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female volunteer
- Aged 18 to 60 years
- Skin phototype I to IV
- Hair length longer than 2 cm, preferably shorter than shoulder length
- Female of childbearing potential not sexually active or using effective contraception, or menopausal/post-menopausal women
- Moderate to severe dandruff at screening and inclusion visits
- Total dandruff score at inclusion ≥ 4.5; adherent dandruff score ≥ 2.5
- Usually shampooing 3 times per week and willing to continue 2-3 times per week during the study
- Agree to use only supplied products throughout the study
- Agree to have a small scalp area sampled and a small area shaved for analysis
- Understand the study and provide voluntary written informed consent
- Affiliated to social security or insurance system
- Willing to comply with study requirements
- Willing not to participate in another clinical study at a different center during this study
- Agree to provide accurate personal information
- Able to attend all study visits
You will not qualify if you...
- Any systemic disorder or scalp disease affecting study results (e.g., seborrheic dermatitis, atopic dermatitis, eczema, psoriasis)
- Pregnant or intending to become pregnant during the study
- Currently breastfeeding or breastfed within 6 months before study start
- Male with alopecia grade ≥ V or female with alopecia grade I-III
- Frizzy hair or significant white hair affecting dandruff scoring
- Scalp skin marks interfering with assessments (pigmentation, tattoo, scarring)
- Use of scalp products like dyeing, bleaching, or perm within 3 weeks before study
- Use of anti-dandruff treatments within 3 weeks before study
- Use of cosmetic anti-hair loss treatments within 3 months or medical treatments within 6 months before study
- History of allergy to anti-dandruff or cosmetic products with surfactants or latex
- Use of systemic or topical corticosteroids, antifungals, antibiotics, NSAIDs, or antihistamines within 1 month before study
- Use of retinoic acid within 3 months before study
- Medications or medical/surgical history affecting study validity or wellbeing
- Immunosuppressed individuals
- History of skin cancer
- Recent changes in hormonal treatment
- Regular water sports or sauna use
- Excessive sun or UV exposure within 1 month before study
- Deprived of liberty by official decision
- Participation in another clinical study with ongoing exclusion period
- Unable to be contacted by phone
- Staff member of the investigating center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants apply the assigned lotion to the scalp to evaluate its effect on dandruff and scalp microbiome balance.
2 visits (Day 0 and Day 28)
Trial Site Locations
Total: 1 location
1
PhD TRIAL
Lisbon, Portugal, 1750-18
Actively Recruiting
Research Team
A
AUDREY GABY GUENICHE, PharmaD and phD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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