Scalp DermatitisNCT04057950
Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic Dermatitis
A study testing cosmetic product in people with Scalp Dermatitis and Dermatitis, run by L'Oreal at 1 site in France.
Trial summary
The aim of this study was to investigate the changes in the scalp bacterial and fungal microbiota in subjects afflicted with a scalp seborrheic dermatitis (SSD) during a 2% ketoconazole-based treatment followed by a maintenance phase (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo versus its vehicle). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scalp Dermatitis, Dermatitis
- What is being tested?
- cosmetic product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 1 Mar 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with hair length > 2 cm.
- Subject exhibiting a slight to moderate seborrheic dermatitis on the scalp after clinical examination, on D0.
- Subject exhibiting slight to severe squame state of scalp: Total squame score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squame score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squame score on D0.
- 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 2 weeks prior to D0.
- Subject usually using seborrheic dermatitis treatments
Who cannot join
- • Main Inclusion Criteria:
- Subject with hair length > 2 cm.
- Subject exhibiting a slight to moderate seborrheic dermatitis on the scalp after clinical examination, on D0.
- Subject exhibiting slight to severe squame state of scalp: Total squame score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squame score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squame score on D0.
- 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 2 weeks prior to D0.
Show all 19Show fewer
- Subject usually using seborrheic dermatitis treatments
- Main Non-Inclusion Criteria:
- Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
- Subject who used topic treatment for the scalp (anti-dandruff, anti-hair loss, soothing) or corticosteroid treatment (per os or topical) during the last two weeks before the start of 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 tensioactive agents
- Subject who has taken: corticoids within 2 weeks before the study entrr, or anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive, or lithium-based drugs less than 1 month before the study entry, or retinoid acid (local or per os) since less than 6 months before study entry.
- Subject with cutaneous affection of the scalp other than seborrheic dermatitis (psoriasis, alopecia in vertex, pediculosis, atopic dermatitis …).
- Subject affected by serious, non-stabilized or progressive disease 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.
About this study
Official title: Multicentric, Randomized, Double Blind Study Under Dermatological Control for Evaluation of the Antidandruff Maintenance Effect of One Shampoo (Reference 1144628 D) Versus Its Vehicle (Reference 1144781) During 8 Weeks After a Ketoconazole-based Antifungal Treatment During 4 Weeks in Adult Subjects (Male and Female) With Light to Moderate Seborrheic Dermatitis
The aim of this study was to investigate the changes in the scalp bacterial and fungal microbiota in subjects afflicted with a scalp seborrheic dermatitis (SSD) during a 2% ketoconazole-based treatment followed by a maintenance phase (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo versus its vehicle).
Read the detailed description
Seborrheic dermatitis is a chronic, recurrent, cutaneous inflammatory condition that causes erythema and skin flaking, sometimes appearing as macules or plaques with dry white or moist oily scales. In general, this condition affects patients in good general health.
In adults, it commonly occurs in areas with high concentrations of sebaceous glands. The scalp is the most frequently affected area (80-90 percent of the cases).
These plaques are usually masked by the hair but covered by abundant dandruff, very visible on the head and even on the clothes. In the severe forms, the dandruff plaques develop into "helmets": they then cover tufts of hair and can cause them to fall.
On the scalp, the lesions may range from mild desquamation to brownish crusts affixed to the skin and hair. Some patients report pruritus, particularly if the scalp is affected. Secondary bacterial infection may occur, aggravating erythema and exudate and causing local discomfort.
Dandruff is regarded as a mild non-inflammatory form of seborrheic dermatitis. The cause of seborrheic dermatitis is not well understood, but its occurrence appears to be related to the proliferation of commensal Malassezia species.
Seborrheic dermatitis often has a substantial negative impact on quality of life and is associated with direct and indirect medical costs.
The primary goals of therapy for seborrheic dermatitis are to clear the visible signs of disease and reduce bothersome symptoms, especially pruritus. Seborrheic dermatitis of the scalp is most conveniently treated with shampoos containing antifungal agents, corticosteroids, or keratolytic agent. They have been shown to be effective in the treatment of seborrheic dermatitis, but recurrence is common and that ongoing treatment may be necessary.
For this study, the choice of the treatment against seborrheic dermatitis was set to ketoconazole, which is a common treatment that shows efficacy.
The purpose of this study is to find a way to ameliorate the quality of life of subjects with seborrheic dermatitis. This trial will evaluate the antidandruff maintenance effect of a 1% selenium sulfide/1% salicylic acid-based shampoo (cosmetic shampoo) versus its vehicle during a 8 week application duration, after the subjects were treated with a classic antifungal treatment for seborrheic dermatitis (in this study, the treatment will be a ketoconazole-based antifungal treatment for 4 weeks in adults with light to moderate seborrheic dermatitis).
- Conditions
- Scalp Dermatitis, Dermatitis
- Being tested
- cosmetic product
- Keywords
- seborrheic dermatitis, microbiota, malassezia, bacteria, diversity
- Medical subject headings
- Dermatitis, Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cosmetic productOther
Also called vichy dercos
Disulfure de sélénium versus placebo formula
| Study group | Role | What they receive |
|---|---|---|
| treating shampoo | Active comparator | treating shampoo (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo) 1144628 D cosmetic product Receives: Other: cosmetic product |
| vehicle | Placebo comparator | 1144781 cosmetic product Receives: Other: cosmetic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antisquame efficacy of the tested shampoo versus its vehicle with Visual Analog Scale after 8 weeks
Change at 8 weeks versus Baseline at 8 weeks of the squamous scale of the shampoo versus vehicle
Measured: before and after 8 weeks of treatement
Secondary outcomes (2)
Change in scalp microbiome (quantification)
change in scalp microbiome (quantification by Polymerase Chain Reaction of Staphylococcus, Propionibacterium, Malassezia)
Measured: before and after 8 week treatment period.
change in scalp microbiome (qualification)
change in scalp microbiome (qualification by Next-Generation Sequencing to evaluate diversities)
Measured: before and after 8 week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Jun 2019
- Primary completion1 Sep 2019
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp DermatitisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yorik DROUAULT, MD, Principal investigator, INTERTECK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057950
- Sponsor's protocol ID
- 17-00182
- Status last verified
- Apr 2021
- First submitted
- 12 Aug 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Antidandruff maintenance effect Comparison of the antidandruff maintenance effect, after a 4 weeks treatment with ketoconazole, of two shampoos (active versus vehicle) applied during 8 weeks i.e. up to week 12 (principal objective) and during 4 and 6 weeks i.e. at week 8 and week 10 (secondary objective).
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Randomized, Double Blind Study Under Dermatological Control for Evaluation of the Antidandruff Maintenance Effect of One Shampoo (Reference 1144628 D) Versus Its Vehicle (Reference 1144781) During 8 Weeks After a Ketoconazole-based Antifungal Treatment During 4 Weeks in Adult Subjects (Male and Female) With Light to Moderate Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT04057950
- Acronym / sponsor ID
- 17-00182
- Conditions
- Scalp Dermatitis, Dermatitis
- Keywords
- seborrheic dermatitis, microbiota, malassezia, bacteria, diversity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 15 Aug 2019 (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 bacterial and fungal microbiota in subjects afflicted with a scalp seborrheic dermatitis (SSD) during a 2% ketoconazole-based treatment followed by a maintenance phase (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo versus its vehicle).
Detailed description
Seborrheic dermatitis is a chronic, recurrent, cutaneous inflammatory condition that causes erythema and skin flaking, sometimes appearing as macules or plaques with dry white or moist oily scales. In general, this condition affects patients in good general health.
In adults, it commonly occurs in areas with high concentrations of sebaceous glands. The scalp is the most frequently affected area (80-90 percent of the cases).
These plaques are usually masked by the hair but covered by abundant dandruff, very visible on the head and even on the clothes. In the severe forms, the dandruff plaques develop into "helmets": they then cover tufts of hair and can cause them to fall.
On the scalp, the lesions may range from mild desquamation to brownish crusts affixed to the skin and hair. Some patients report pruritus, particularly if the scalp is affected. Secondary bacterial infection may occur, aggravating erythema and exudate and causing local discomfort.
Dandruff is regarded as a mild non-inflammatory form of seborrheic dermatitis. The cause of seborrheic dermatitis is not well understood, but its occurrence appears to be related to the proliferation of commensal Malassezia species.
Seborrheic dermatitis often has a substantial negative impact on quality of life and is associated with direct and indirect medical costs.
The primary goals of therapy for seborrheic dermatitis are to clear the visible signs of disease and reduce bothersome symptoms, especially pruritus. Seborrheic dermatitis of the scalp is most conveniently treated with shampoos containing antifungal agents, corticosteroids, or keratolytic agent. They have been shown to be effective in the treatment of seborrheic dermatitis, but recurrence is common and that ongoing treatment may be necessary.
For this study, the choice of the treatment against seborrheic dermatitis was set to ketoconazole, which is a common treatment that shows efficacy.
The purpose of this study is to find a way to ameliorate the quality of life of subjects with seborrheic dermatitis. This trial will evaluate the antidandruff maintenance effect of a 1% selenium sulfide/1% salicylic acid-based shampoo (cosmetic shampoo) versus its vehicle during a 8 week application duration, after the subjects were treated with a classic antifungal treatment for seborrheic dermatitis (in this study, the treatment will be a ketoconazole-based antifungal treatment for 4 weeks in adults with light to moderate seborrheic dermatitis).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treating shampoo | Active comparator | Other: cosmetic producttreating shampoo (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo) 1144628 D cosmetic product |
| vehicle | Placebo comparator | Other: cosmetic product1144781 cosmetic product |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject with hair length > 2 cm.
- Subject exhibiting a slight to moderate seborrheic dermatitis on the scalp after clinical examination, on D0.
- Subject exhibiting slight to severe squame state of scalp: Total squame score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squame score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squame score on D0.
- 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 2 weeks prior to D0.
Key exclusion criteria (19 listed)
- • Main Inclusion Criteria:
- Subject with hair length > 2 cm.
- Subject exhibiting a slight to moderate seborrheic dermatitis on the scalp after clinical examination, on D0.
- Subject exhibiting slight to severe squame state of scalp: Total squame score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squame score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squame score on D0.
- Subject usually using a shampoo 3 times a week and accepting to follow this rate during the whole study period.
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 |
|---|---|---|
| cosmetic productAlso: vichy dercosDisulfure de sélénium versus placebo formula | Other | treating shampoo, vehicle |
Primary outcome
Antisquame efficacy of the tested shampoo versus its vehicle with Visual Analog Scale after 8 weeks
Time frame: before and after 8 weeks of treatement
Change at 8 weeks versus Baseline at 8 weeks of the squamous scale of the shampoo versus vehicle
2 secondary outcomes
Change in scalp microbiome (quantification)
Time frame: before and after 8 week treatment period.
change in scalp microbiome (qualification)
Time frame: before and after 8 week treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: Yes. Antidandruff maintenance effect Comparison of the antidandruff maintenance effect, after a 4 weeks treatment with ketoconazole, of two shampoos (active versus vehicle) applied during 8 weeks i.e. up to week 12 (principal objective) and during 4 and 6 weeks i.e. at week 8 and week 10 (secondary objective).
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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.
Yorik DROUAULT, MD principal investigator
INTERTECK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cosmetic product in people with Scalp Dermatitis and Dermatitis, 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 6 inclusion and 19 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: finished, as of the sponsor's last update on 27 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antisquame efficacy of the tested shampoo versus its vehicle with Visual Analog Scale after 8 weeks (time frame: before and after 8 weeks of treatement). 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 27 Apr 2021.