DandruffNCT06813521
Antidandruff Lotion Mediating Microbiome Rebalance
A study testing NaP1%+VitCG3% leave-on lotion (formula 1256103) and reference Octopirox 0.25% (formula 1256149). in people with Dandruff, run by L'Oreal at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dandruff
- What is being tested?
- NaP1%+VitCG3% leave-on lotion (formula 1256103) and reference Octopirox 0.25% (formula 1256149).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 20Show fewer
- 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.
Who cannot join
- 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;
Show all 48Show fewer
- 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;
- Female subject who is currently breast-feeding or have been breast-feeding in the 6 months prior to the start of the study;
- Male subject with alopecia grade ≥ V according to Hamilton-Norwood patterns, female subject with alopecia grade I, II or III according to Ludwig patterns (Appendix 3);
- Subject with frizzy hair influencing the scoring of dandruff;
- Subject with significant white hair influencing the scoring of dandruff;
- Subject who has skin marks on the scalp that could interfere with the assessments (e.g. pigmentation, tattoo, scarring etc.);
- Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study;
- Subject who has used anti-dandruff treatment (per os or topical) during the last three weeks before the start of the study;
- Subject who has used cosmetic anti-hair loss treatment (per os or topical) during the last three months before the start of the study, or/and subject who has used medical anti-hair loss treatment (per os or topical, ex: Minoxidil, finasteride, etc…) during the last six months before the start of the study;
- Subject with personal history of allergy and/or particular reactivity to antidandruff products, and/or to cosmetic products containing tensioactive agents (soaps, shower gel, conditioner …), and/or to latex;
- Subject who has taken any systemic drug containing corticoids, or anti-fungal, or antibiotics, or any prolonged use of topical drug containing corticoids, or anti-fungal, or antibiotics, or any prolonged use of non-steroidal anti-inflammatory, or anti-histaminic within one month prior to the study;
- Subject who has taken retinoic acid since less than three months prior to the study;
- Subject receiving other medication which, in the opinion of the investigator, will affect either the scientific validity of the study or the subject's wellbeing.
- Subject with a history of medical/surgical events (or surgical events planned) which, in the opinion of the investigator, will affect either the scientific validity of the study or the subject's wellbeing;
- Immunosuppressed subject;
- Subject with medical history of skin cancer;
- Subject who has started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study;
- Subject practicing regularly water sports and/or having sauna sessions;
- Subject exposed to the sun or UV rays in an excessive way during the last month prior to the study (according to the investigator);
- Subject deprived of liberty by adjunction or by official decision;
- Subject who is participating or who has participated to a clinical study for which the exclusion period is not finished;
- Subject unable to be contacted by phone;
- Subject belonging to the staff of the investigating center.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
PhD TRIAL
Lisbon, 1750-18
Pedro CONTREIRAS PINTO, MD PhD, +351216034267 ext. +351, geral@phdtrials.com
Pedro Contreiras, MD PhD
About this study
Official title: Evaluation of the Effect of a Lotion on Antidandruff and on Mediating Microbiome Rebalance Versus Vehicle and Reference on Volunteers
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.
Read more
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
- Being tested
- NaP1%+VitCG3% leave-on lotion (formula 1256103), vehicle (formula 1256145), reference Octopirox 0.25% (formula 1256149).
- Keywords
- lotion, antidandruff, microbiome rebalance
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaP1%+VitCG3% leave-on lotion (formula 1256103)Other
leave-on lotion
vehicle (formula 1256145)Other
vehicle lotion
reference Octopirox 0.25% (formula 1256149).Other
lotion reference Octopirox 0.25%
| Study group | Role | What they receive |
|---|---|---|
| NaP1%+VitCG3% leave-on lotion | Experimental | Not described Receives: Other: NaP1%+VitCG3% leave-on lotion (formula 1256103) |
| vehicle | Placebo comparator | Not described Receives: Other: vehicle (formula 1256145) |
| Reference Octopirox 0.25% | Active comparator | Not described Receives: Other: reference Octopirox 0.25% (formula 1256149). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0 and Day 28
Secondary outcomes (1)
Analysis of Malassezia sp, Cutibacterium sp and Staphylococcus sp
qPCR Malassezia sp, Cutibacterium sp and Staphylococcus sp
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Sep 2024
- Primary completion2 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DandruffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cosmetic product
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813521
- Sponsor's protocol ID
- ACR-PAN1-19-01989
- Status last verified
- Feb 2025
- First submitted
- 12 Nov 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Lotion on Antidandruff and on Mediating Microbiome Rebalance Versus Vehicle and Reference on Volunteers
- ClinicalTrials.gov ID
- NCT06813521
- Acronym / sponsor ID
- ACR-PAN1-19-01989
- Conditions
- Dandruff
- Keywords
- lotion, antidandruff, microbiome rebalance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- cosmetic product
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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);
Key exclusion criteria (48 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaP1%+VitCG3% leave-on lotion (formula 1256103)leave-on lotion | Other | NaP1%+VitCG3% leave-on lotion |
| vehicle (formula 1256145)vehicle lotion | Other | vehicle |
| reference Octopirox 0.25% (formula 1256149).lotion reference Octopirox 0.25% | Other | Reference Octopirox 0.25% |
Primary outcome
Global score of dandruff status of the scalp: evaluation of adherent and non-adherent dandruff according
Time frame: Day 0 and Day 28
scale ranging from 0 (no dandruff) to 5 (maximum score of dandruff adherent and non adherent)
1 secondary outcome
Analysis of Malassezia sp, Cutibacterium sp and Staphylococcus sp
Time frame: Day 0 and Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaP1%+VitCG3% leave-on lotion (formula 1256103) and reference Octopirox 0.25% (formula 1256149). in people with Dandruff, run by L'Oreal at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AUDREY GABY GUENICHE, PharmaD and phD (+33660992467 ext. +33, audrey.gueniche@loreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global score of dandruff status of the scalp: evaluation of adherent and non-adherent dandruff according (time frame: Day 0 and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.