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NCT06813521
Antidandruff Lotion Mediating Microbiome Rebalance
NA trial testing NaP1%+VitCG3% leave-on lotion (formula 1256103) in Dandruff in 120 participants. Currently enrolling.
2 May 2025
Quick facts
| Lead sponsor | L'Oreal |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 September 2024 |
| Primary completion | 2 May 2025 |
| Estimated completion | 1 June 2025 |
| Sites | 1 location across Portugal |
Drugs / interventions tested
- NaP1%+VitCG3% leave-on lotion (formula 1256103)
- vehicle (formula 1256145)
- reference Octopirox 0.25% (formula 1256149).
Conditions studied
- Dandruff — all drugs for Dandruff →
Sponsor
L'Oreal — full company profile →
Who can join
Adults 18 to 60, any sex, with Dandruff. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06813521
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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- medRxiv preprints
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Related trials
Other L'Oreal trials
Trials by the same sponsor.
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- NCT06937515 — MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT · completed
- NCT07462845 — Agents Effect Under Visible Light on Caucasian, Asian and Darker Skin Types · completed
- NCT05502185 — Targeting Staphylococci in Atopic Dermatitis · unknown
- NCT06945393 — ANTIPIGMENTING OR DEPIMENTING EFFICACY UNDER PART OF VISIBLE LIGHT · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06813521 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by L'Oreal
- Last refreshed: 7 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06813521.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing