DandruffNCT05506592
Evaluation of the Efficacy of SeS2 Shampoo on Subjects Having Dandruff
A study testing dermatological product in people with Dandruff, run by L'Oreal at 1 site in France.
Trial summary
A shampoo containing SeS2 was evaluated versus placebo on healthy subjects suffering from dandruff in order to assess clinical benefits and its impact on fungal and bacterial scalp microbiota. 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?
- dermatological product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 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
- Healthy male or female volunteers;
- Age: 18 to 60 years old included;
- Phototype (Fitzpatrick): I to IV;
- Subjects with hair length > 2 cm, and preferentially shorter than shoulder length;
- Females of childbearing potential, who are sexually actives, using an effective contraceptive method* for at least one month before the beginning of the study, and throughout the study;
- Subjects exhibiting moderate to severe dandruff status of scalp at screening
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- Subjects 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;
- Subjects having on inclusion Day 0, 2 areas with dandruff (score > 2.5) (one of 1x1cm2, the other of 2 x 2cm2) and 2 areas without dandruff (score < 1) (one of 1x1cm2, the other of 2 x 2cm2) in the vertex if possible
- Subjects usually using a shampoo 3 times/week and willing to have three times/week shampoos during the course of the study;
- Subjects agreeing to use only the supplied shampoo during all the study;
- Subjects agreeing to have 4 hair areas on the scalp (2 areas of approximately 2 cm x 2 cm and 2 areas approximately 1cmx1cm) for micro flora sample taking (swabs);
- Subjects agreeing to have hair cut around the 4 identified areas (zone of 1x0.5cm cut on the high corner of each area sampling)
- Subjects 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;
- Subjects willing to comply to the study requirements;
- Subjects who are willing not to take part in another clinical study in another investigating centre;
- Subjects who agree to give accurate personal information;
- Subjects who are able to attend all study visits. * The effective contraceptive methods: sexually active females 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
- Healthy male or female volunteers;
- Age: 18 to 60 years old included;
- Phototype (Fitzpatrick): I to IV;
- Subjects with hair length > 2 cm, and preferentially shorter than shoulder length;
- Females of childbearing potential, who are sexually actives, using an effective contraceptive method* for at least one month before the beginning of the study, and throughout the study;
- Subjects exhibiting moderate to severe dandruff status of scalp at screening and at D-3;
- Subjects 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;
- Subjects having on inclusion Day 0, 2 areas with dandruff (score > 2.5) (one of 1x1cm2, the other of 2 x 2cm2) and 2 areas without dandruff (score < 1) (one of 1x1cm2, the other of 2 x 2cm2) in the vertex if possible
- Subjects usually using a shampoo 3 times/week and willing to have three times/week shampoos during the course of the study;
- Subjects agreeing to use only the supplied shampoo during all the study;
- Subjects agreeing to have 4 hair areas on the scalp (2 areas of approximately 2 cm x 2 cm and 2 areas approximately 1cmx1cm) for micro flora sample taking (swabs);
- Subjects agreeing to have hair cut around the 4 identified areas (zone of 1x0.5cm cut on the high corner of each area sampling)
- Subjects 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;
- Subjects willing to comply to the study requirements;
- Subjects who are willing not to take part in another clinical study in another investigating centre;
- Subjects who agree to give accurate personal information;
- Subjects who are able to attend all study visits. * The effective contraceptive methods: sexually active females 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
- Subjects with any systemic disorder or skin 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);
- Subjects with cutaneous affection of the scalp (psoriasis, atopic dermatitis, seborrheic dermatitis which shows the syndrome of invasion plaque and/or pityriasis amiantacea, …);
- Female subjects who are known to be pregnant or who are intending to become pregnant over the duration of the study;
- Female subjects who are currently breast-feeding or have been breast-feeding in the 6 months prior to the start of the study;
- Male subjects with alopecia grade ≥ V according to Hamilton-Norwood patterns, female subjects with alopecia grade I, II or III according to Ludwig patterns;
- Subjects with frizzy hair influencing the scoring of dandruff;
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- Subjects with significant white hair influencing the scoring of dandruff;
- Subjects who have skin marks on the scalp that could interfere with the assessments (e.g. pigmentation, tattoo, scarring etc.);
- Subjects who have used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study;
- Subjects who have used anti-dandruff treatment (per os or topical) during the last three weeks before the start of the study;
- Subjects who have used cosmetic anti-hairloss 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;
- Subjects 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;
- Subjects who have 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;
- Subjects who have taken retinoic acid since less than three months prior to the study;
- Subjects receiving other medication which, in the opinion of the investigator, will affect either the scientific validity of the study or the subject's wellbeing.
- Subjects 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;
- Subjects with medical history of skin cancer;
- Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study;
- Subjects practicing regularly water sports and/or having regularly sauna sessions;
- Subjects exposed to the sun or UV rays in an excessive way during the last month prior to the study (according to the investigator);
- Subjects deprived of liberty by adjunction or by official decision;
- Subjects who are participating or who has participated to a clinical study for which the exclusion period is not finished;
- Subjects unable to be contacted by phone;
- Subjects belonging to the staff of the investigating centre
Trial locations and contacts
1 site in 1 country.
France1 site
Interteck
Paris, 75013
BERENGERE GUIDET, pHD, 0153687903 ext. +33, berengere.guidet@intertek.com
About this study
Official title: Evaluation of the Efficacy of an Anti Dandruff Shampoo Against Placebo on Dandruff and Scalp Microflora Composition After 4 Weeks of Treatment and 4 Weeks of Relapse
A shampoo containing SeS2 was evaluated versus placebo on healthy subjects suffering from dandruff in order to assess clinical benefits and its impact on fungal and bacterial scalp microbiota.
- Conditions
- Dandruff
- Being tested
- dermatological product
- Keywords
- Squamous, Malassezia, bacteria
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dermatological productOther
cosmetic shampoo
| Study group | Role | What they receive |
|---|---|---|
| Selenium disulfide shampoo | Active comparator | Not described Receives: Other: dermatological product |
| placebo shampoo | Placebo comparator | Not described Receives: Other: dermatological product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of microflora from swabs for fungi quantification
malassezia qPCR
Measured: 1 month
Analysis of microflora from swabs for bacteria quantification
Cutibacterium qPCR
Measured: 1 month
Analysis of microflora from swabs for bacteria diversity
sequencing 16S
Measured: 1 month
Analysis of microflora from swabs for fungi diversity
sequencing ITS
Measured: 1 month
Secondary outcomes (1)
Grading of Dandruff severity
Dandruff severity 0-5 ordinal scale
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 posted18 Aug 2022
- Study startOct 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the impact of an anti-dandruff shampoo compared to vehicle (placebo) on scalp microflora composition after 4 weeks of treatment and 4 weeks of relapse, on healthy volunteers with moderate to severe dandruff status
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT05506592
- Sponsor's protocol ID
- ACR_VICO_1411
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of an Anti Dandruff Shampoo Against Placebo on Dandruff and Scalp Microflora Composition After 4 Weeks of Treatment and 4 Weeks of Relapse
- ClinicalTrials.gov ID
- NCT05506592
- Acronym / sponsor ID
- ACR_VICO_1411
- Conditions
- Dandruff
- Keywords
- Squamous, Malassezia, bacteria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 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.
A shampoo containing SeS2 was evaluated versus placebo on healthy subjects suffering from dandruff in order to assess clinical benefits and its impact on fungal and bacterial scalp microbiota.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To evaluate the impact of an anti-dandruff shampoo compared to vehicle (placebo) on scalp microflora composition after 4 weeks of treatment and 4 weeks of relapse, on healthy volunteers with moderate to severe dandruff status
| Arm | Type | Receives |
|---|---|---|
| Selenium disulfide shampoo | Active comparator | Other: dermatological product |
| placebo shampoo | Placebo comparator | Other: dermatological product |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (42 listed)
- Healthy male or female volunteers;
- Age: 18 to 60 years old included;
- Phototype (Fitzpatrick): I to IV;
- Subjects with hair length > 2 cm, and preferentially shorter than shoulder length;
- Females of childbearing potential, who are sexually actives, using an effective contraceptive method* for at least one month before the beginning of the study, and throughout the study;
Key exclusion criteria (25 listed)
- Subjects with any systemic disorder or skin 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);
- Subjects with cutaneous affection of the scalp (psoriasis, atopic dermatitis, seborrheic dermatitis which shows the syndrome of invasion plaque and/or pityriasis amiantacea, …);
- Female subjects who are known to be pregnant or who are intending to become pregnant over the duration of the study;
- Female subjects who are currently breast-feeding or have been breast-feeding in the 6 months prior to the start of the study;
- Male subjects with alopecia grade ≥ V according to Hamilton-Norwood patterns, female subjects with alopecia grade I, II or III according to Ludwig patterns;
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 |
|---|---|---|
| dermatological productcosmetic shampoo | Other | Selenium disulfide shampoo, placebo shampoo |
Primary outcome
Analysis of microflora from swabs for fungi quantification
Time frame: 1 month
malassezia qPCR
Analysis of microflora from swabs for bacteria quantification
Time frame: 1 month
Cutibacterium qPCR
Analysis of microflora from swabs for bacteria diversity
Time frame: 1 month
sequencing 16S
Analysis of microflora from swabs for fungi diversity
Time frame: 1 month
sequencing ITS
1 secondary outcome
Grading of Dandruff severity
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 18 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dermatological product in people with 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 42 inclusion and 25 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 18 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sayeh POURHAMIDI, pHD (0660992467 ext. +33, sayeh.pourhamidi@rd.loreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of microflora from swabs for fungi quantification (time frame: 1 month). The study lists 4 primary outcomes in all. 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 18 Aug 2022.