DandruffNCT05503706
Effects on the Scalp Lipids and TEWL of a 1% Selenium Disulfide and 1% Salicylic Acid Antidandruff Shampoo on Dandruff Scalp
A study of Dandruff, run by L'Oreal at 1 site in France.
Trial summary
The aim of this study was to investigate the changes in the scalp lipids and TEWL in dandruff subjects treated by 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo after an antidandruff treatment and after a remanence phase Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dandruff
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject with hair length > 2 cm.
- Subject exhibiting slight to severe dandruff state of scalp: Total dandruff score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including and adherent dandruff score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent dandruff score, after clinical examination 3 days after the last shampoo performed on D-3.
- Subject with slight itching state of scalp: score before shampoo ≥3 (ranging from 0 to 9,) 3 days after the last shampoo performed on D-3.
- Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
- Subject having stopped any possible antidandruff treatment at least 1 week prior to study pre-inclusion.
- Subject usually using anti-dandruff products.
- Subject agreeing not to use any other cosmetic product on the air (tonic,lacquer, gel, mousse) and not colouring or bleaching hair until the end of study
Who cannot join
- Main Inclusion Criteria:
- Subject with hair length > 2 cm.
- Subject exhibiting slight to severe dandruff state of scalp: Total dandruff score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including and adherent dandruff score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent dandruff score, after clinical examination 3 days after the last shampoo performed on D-3.
- Subject with slight itching state of scalp: score before shampoo ≥3 (ranging from 0 to 9,) 3 days after the last shampoo performed on D-3.
- Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
- Subject having stopped any possible antidandruff treatment at least 1 week prior to study pre-inclusion.
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- Subject usually using anti-dandruff products.
- Subject agreeing not to use any other cosmetic product on the air (tonic,lacquer, gel, mousse) and not colouring or bleaching hair until the end of study
- Main Non-Inclusion Criteria:
- Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
- Subject who has used topic treatment for the scalp (anti-dandruff, antihairloss) or corticosteroid treatment (per os or topical) during the last two weeks before the start of the study.
- Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the 2 weeks prior to the study.
- Subject with personal history of allergy and/or particular reactivity to antidandruff products.
- Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)
- Subject who has taken a drug containing lithium, corticoids, during the last month; anti-histaminic, anti-fungal, non-steroidal anti-inflammatory or immunosuppressive drugs during the last 7 days.
- Subject who has taken retinoid acid (local or per os) since less than 6 months.
- Subject with cutaneous affection of the scalp (psoriasis, atopic dermatitis, seborrheic dermatitis, alopecia …).
- Subject affected by serious, non-stabilized or progressive disease (according to the investigator) as diabetes, hypertension, hypothyroidism or hyperthyroidism which may influence the evolution of studied cutaneous state and morphology.
- Subject affected by serious pathology (cancer, immune-depressed)
- Subject who has undergone a surgical operation in the previous month of the study or having planned it during the study.
- Subject, who has started, stopped or changed of hormonal treatment (including contraceptive pill) in the previous 6 weeks.
- Pregnancy or breastfeeding during the last 6 months, ongoing or planned during the study
Trial locations and contacts
1 site in 1 country.
France1 site
DERMSCAN
Villeurbanne, 69100
Sophie CHARTIER, pHD, 04 72 82 36 56 ext. +33, SCH@dermscan.com
About this study
Official title: Evaluation of the Antidandruff Effect of a Shampoo on Subjects With Dandruff and Slight Itching. Single-blind, Monocentric Study Realized Under Dermatological Control
The aim of this study was to investigate the changes in the scalp lipids and TEWL in dandruff subjects treated by 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo after an antidandruff treatment and after a remanence phase
Read the detailed description
Dandruf often has a substantial negative impact on quality of life. The proliferation of Malassezia specie has been shown to be linked to dandruff. Yet, the sebum is essential for the growth of Malassezia restricta.
The sebum is mainly constituted by waxes, squalene and triglycerides. The triglycerides are partially transformed in free fatty acids while the squalene can be oxidized. Therefore, the change in lipids can be of interest for dandruff studies.
The scalp barrier function of a dandruff scalp is known to be altered and must recover after an antidandruff treatment
The aim of this study is to investigate the change of the scalp lipids and TEWL after a 1% selenium disulfide and 1% salicylic acid antidandruff shampoo on dandruff scalp and after a remanence period
- Conditions
- Dandruff
- Being tested
- 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampooOther
dandruff shampoo
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change of squame quantity during the antidandruff treatment
squame level clinical scoring evaluation (adherent squame, non-adherent squame and total squame).
Measured: 1 month
Secondary outcomes (2)
Evaluate the change in scalp barrier function and lipids (glycerides, free fatty acids, squalene and peroxidized squalene) after the antidandruff treatment
Trans epidermal barrier by instrumental evaluation and lipids by chromatography
Measured: 1 month
Evaluation of the scalp barrier function
The evaluation of the scalp barrier function was done by Transepidermal Water Loss (TEWL) measurement.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AUDREY GUENICHE, PHD, Study chair, L'Oreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503706
- Sponsor's protocol ID
- ACR_VICO1BIS
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 17 Aug 2022
- 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 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antidandruff Effect of a Shampoo on Subjects With Dandruff and Slight Itching. Single-blind, Monocentric Study Realized Under Dermatological Control
- ClinicalTrials.gov ID
- NCT05503706
- Acronym / sponsor ID
- ACR_VICO1BIS
- Conditions
- Dandruff
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Aug 2022 (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.
The aim of this study was to investigate the changes in the scalp lipids and TEWL in dandruff subjects treated by 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo after an antidandruff treatment and after a remanence phase
Detailed description
Dandruf often has a substantial negative impact on quality of life. The proliferation of Malassezia specie has been shown to be linked to dandruff. Yet, the sebum is essential for the growth of Malassezia restricta.
The sebum is mainly constituted by waxes, squalene and triglycerides. The triglycerides are partially transformed in free fatty acids while the squalene can be oxidized. Therefore, the change in lipids can be of interest for dandruff studies.
The scalp barrier function of a dandruff scalp is known to be altered and must recover after an antidandruff treatment
The aim of this study is to investigate the change of the scalp lipids and TEWL after a 1% selenium disulfide and 1% salicylic acid antidandruff shampoo on dandruff scalp and after a remanence period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject with hair length > 2 cm.
- Subject exhibiting slight to severe dandruff state of scalp: Total dandruff score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including and adherent dandruff score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent dandruff score, after clinical examination 3 days after the last shampoo performed on D-3.
- Subject with slight itching state of scalp: score before shampoo ≥3 (ranging from 0 to 9,) 3 days after the last shampoo performed on D-3.
- Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
- Subject having stopped any possible antidandruff treatment at least 1 week prior to study pre-inclusion.
Key exclusion criteria (22 listed)
- Main Inclusion Criteria:
- Main Non-Inclusion Criteria:
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 |
|---|---|---|
| 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoodandruff shampoo | Other | – |
Primary outcome
Evaluate the change of squame quantity during the antidandruff treatment
Time frame: 1 month
squame level clinical scoring evaluation (adherent squame, non-adherent squame and total squame).
2 secondary outcomes
Evaluate the change in scalp barrier function and lipids (glycerides, free fatty acids, squalene and peroxidized squalene) after the antidandruff treatment
Time frame: 1 month
Evaluation of the scalp barrier function
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- 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. This study is not recruiting at the moment.
AUDREY GUENICHE, PHD study chair
L'Oreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dandruff, run by L'Oreal at 1 site in France.
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 7 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. 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 France. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe MASSIOT, pHD (0660992467 ext. +33, philippe.massiot@rd.loreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the change of squame quantity during the antidandruff treatment (time frame: 1 month). 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 17 Aug 2022.