DandruffNCT05989633
DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
An observational study of Dandruff, run by Cosmetique Active International at 1 site in Poland.
Trial summary
The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dandruff
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,131 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jul 2022to 29 Jun 2023
- Phase
- Observational
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Subjects with dandruff or seborrheic dermatitis
Who may be able to join
- Patients with dandruff or seborrheic dermatitis
- All hair types
- All ethnicities (Asian, Caucasian, Afro-American, African, Hispanic)
- Including patients with specific occlusion habits (for instance veil use at least 8 hours per day, hat use)
- Patients willing to provide written informed consent
Who cannot join
- Under 12 years old
- Pregnancy, breast feeding, childbearing potential without adequate contraception, or irregular menstrual cycles.
- History of allergy, anaphylaxis or hypersensitivity to any of the ingredients of Shampoo any of the ingredients of DERCOS ANTI-DANDRUFF normal to oily hair shampoo
- History of allergic contact dermatitis secondary to shampoo, conditioner, mask, and/or leave-in.
- Has any clinical manifestations in the treatment(s) or other disorders that, in the opinion of the investigator, may affect the evaluations or results of the study products.- Inability to stay the study period (56 days +-5 days) without performing any hair/scalp procedure, including coloring, straightening and cutting.
- Inability to attend all study visits and follow treatment regimen
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS
- Conditions
- Dandruff
- Being tested
- Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)
- Keywords
- dandruff, treatment satisfaction
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)Other
to assess the benefit of Dercos DS in subjects with dandruff
What is being measured
The primary outcome is the main question the study is designed to answer.
Desquamation
Scale (0=absence to 4= very severe)
Measured: Baseline
Desquamation
Scale (0=absence to 4= very severe)
Measured: Day 28
Desquamation
Scale (0=absence to 4= very severe)
Measured: Day 56
Irritation
Scale (0=absence to 4= very severe)
Measured: baseline
Irritation
Scale (0=absence to 4= very severe)
Measured: Day 28
Irritation
Scale (0=absence to 4= very severe)
Measured: Day 56
Erythema
Scale (0=absence to 4= very severe)
Measured: baseline
Erythema
Scale (0=absence to 4= very severe)
Measured: Day 28
Erythema
Scale (0=absence to 4= very severe)
Measured: Day 56
Itching
Scale (0=absence to 10= very severe)
Measured: baseline
Itching
Scale (0=absence to 10= very severe)
Measured: Day 28
Itching
Scale (0=absence to 10= very severe)
Measured: Day 56
Area involved
scale from <10% to >90%
Measured: baseline
Area involved
scale from <10% to >90%
Measured: Day 28
Area involved
scale from <10% to >90%
Measured: Day 56
Tolerance
scale from 0= none to 5=very tolerated
Measured: baseline
Tolerance
scale from 0= none to 5=very tolerated
Measured: Day 28
Improvement
scale from 0= worse to 5=very clearly improved
Measured: Day 28
Improvement
scale from 0= worse to 5=very clearly improved
Measured: Day 56
Impact of dandruff on patient
Scale from 0=not bothered at all to 5=very bothered
Measured: baseline
Impact of dandruff on patient
Scale from 0=not bothered at all to 5=very bothered
Measured: Day 28
Impact of dandruff on patient
Scale from 0=not bothered at all to 5=very bothered
Measured: Day 56
Global evaluation by investigator
Scale from 0=not at all satisfactory at all to 4=very satisfactory
Measured: Day 28
Global evaluation by investigator
Scale from 0=not at all satisfactory at all to 4=very satisfactory
Measured: Day 56
Assessment of hair fiber and quality
scale from 0=worsened to 4=very improved
Measured: Day 56
Product respect/protects hair fiber
scale from 0=no, it is now more damaged/dry than before the treatment to 3=Yes, my hair fiber looks/feels better than before the treatment
Measured: Day 56
Patient product efficacy satisfaction
questionnare with scale ranging from 0=completely disagree to 5=completely agree
Measured: Day 28
Patient product efficacy satisfaction
questionnare with scale ranging from 0=completely disagree to 5=completely agree
Measured: Day 56
Patient product acceptability
scale ranging from 0=not satisfied at all to 10=very satisfied
Measured: Day 28
Patient product acceptability
scale ranging from 0=not satisfied at all to 10=very satisfied
Measured: Day 56
Patient global satisfaction
scale ranging from 0=not satisfied at all to 10=very satisfied
Measured: Day 28
Patient global satisfaction
scale ranging from 0=not satisfied at all to 10=very satisfied
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start4 Jul 2022
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989633
- Sponsor's protocol ID
- Dercos DS in Dandruff
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
- ClinicalTrials.gov ID
- NCT05989633
- Acronym / sponsor ID
- Dercos DS in Dandruff
- Conditions
- Dandruff
- Keywords
- dandruff, treatment satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,131 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 14 Aug 2023 (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 is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with dandruff or seborrheic dermatitis
Key inclusion criteria (5 listed)
- Patients with dandruff or seborrheic dermatitis
- All hair types
- All ethnicities (Asian, Caucasian, Afro-American, African, Hispanic)
- Including patients with specific occlusion habits (for instance veil use at least 8 hours per day, hat use)
- Patients willing to provide written informed consent
Key exclusion criteria (6 listed)
- Under 12 years old
- Pregnancy, breast feeding, childbearing potential without adequate contraception, or irregular menstrual cycles.
- History of allergy, anaphylaxis or hypersensitivity to any of the ingredients of Shampoo any of the ingredients of DERCOS ANTI-DANDRUFF normal to oily hair shampoo
- History of allergic contact dermatitis secondary to shampoo, conditioner, mask, and/or leave-in.
- Has any clinical manifestations in the treatment(s) or other disorders that, in the opinion of the investigator, may affect the evaluations or results of the study products.- Inability to stay the study period (56 days +-5 days) without performing any hair/scalp procedure, including coloring, straightening and cutting.
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 |
|---|---|---|
| Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)to assess the benefit of Dercos DS in subjects with dandruff | Other | – |
Primary outcome
Desquamation
Time frame: Baseline
Scale (0=absence to 4= very severe)
Desquamation
Time frame: Day 28
Scale (0=absence to 4= very severe)
Desquamation
Time frame: Day 56
Scale (0=absence to 4= very severe)
Irritation
Time frame: baseline
Scale (0=absence to 4= very severe)
Irritation
Time frame: Day 28
Scale (0=absence to 4= very severe)
Irritation
Time frame: Day 56
Scale (0=absence to 4= very severe)
Erythema
Time frame: baseline
Scale (0=absence to 4= very severe)
Erythema
Time frame: Day 28
Scale (0=absence to 4= very severe)
Erythema
Time frame: Day 56
Scale (0=absence to 4= very severe)
Itching
Time frame: baseline
Scale (0=absence to 10= very severe)
Itching
Time frame: Day 28
Scale (0=absence to 10= very severe)
Itching
Time frame: Day 56
Scale (0=absence to 10= very severe)
Area involved
Time frame: baseline
scale from <10% to >90%
Area involved
Time frame: Day 28
scale from <10% to >90%
Area involved
Time frame: Day 56
scale from <10% to >90%
Tolerance
Time frame: baseline
scale from 0= none to 5=very tolerated
Tolerance
Time frame: Day 28
scale from 0= none to 5=very tolerated
Improvement
Time frame: Day 28
scale from 0= worse to 5=very clearly improved
Improvement
Time frame: Day 56
scale from 0= worse to 5=very clearly improved
Impact of dandruff on patient
Time frame: baseline
Scale from 0=not bothered at all to 5=very bothered
Impact of dandruff on patient
Time frame: Day 28
Scale from 0=not bothered at all to 5=very bothered
Impact of dandruff on patient
Time frame: Day 56
Scale from 0=not bothered at all to 5=very bothered
Global evaluation by investigator
Time frame: Day 28
Scale from 0=not at all satisfactory at all to 4=very satisfactory
Global evaluation by investigator
Time frame: Day 56
Scale from 0=not at all satisfactory at all to 4=very satisfactory
Assessment of hair fiber and quality
Time frame: Day 56
scale from 0=worsened to 4=very improved
Product respect/protects hair fiber
Time frame: Day 56
scale from 0=no, it is now more damaged/dry than before the treatment to 3=Yes, my hair fiber looks/feels better than before the treatment
Patient product efficacy satisfaction
Time frame: Day 28
questionnare with scale ranging from 0=completely disagree to 5=completely agree
Patient product efficacy satisfaction
Time frame: Day 56
questionnare with scale ranging from 0=completely disagree to 5=completely agree
Patient product acceptability
Time frame: Day 28
scale ranging from 0=not satisfied at all to 10=very satisfied
Patient product acceptability
Time frame: Day 56
scale ranging from 0=not satisfied at all to 10=very satisfied
Patient global satisfaction
Time frame: Day 28
scale ranging from 0=not satisfied at all to 10=very satisfied
Patient global satisfaction
Time frame: Day 56
scale ranging from 0=not satisfied at all to 10=very satisfied
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 14 Aug 2023.
- Individual participant dataSharing planned: No
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Recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dandruff, run by Cosmetique Active International at 1 site in Poland.
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 5 inclusion and 6 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 14 Aug 2023. 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 Poland. 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?
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?
Desquamation (time frame: Baseline). The study lists 32 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 14 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.