Clinical trial NCT05989633: DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
Official title: DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dandruff
Keywords: dandruff
treatment satisfaction
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 5131
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with dandruff or seborrheic dermatitis

Brief summary: The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Desquamation
timeFrame: Baseline
measure: Desquamation
timeFrame: Day 28
measure: Desquamation
timeFrame: Day 56
measure: Irritation
timeFrame: baseline
measure: Irritation
timeFrame: Day 28
measure: Irritation
timeFrame: Day 56
measure: Erythema
timeFrame: baseline
measure: Erythema
timeFrame: Day 28
measure: Erythema
timeFrame: Day 56
measure: Itching
timeFrame: baseline
measure: Itching
timeFrame: Day 28
measure: Itching
timeFrame: Day 56
measure: Area involved
timeFrame: baseline
measure: Area involved
timeFrame: Day 28
measure: Area involved
timeFrame: Day 56
measure: Tolerance
timeFrame: baseline
measure: Tolerance
timeFrame: Day 28
measure: Improvement
timeFrame: Day 28
measure: Improvement
timeFrame: Day 56
measure: Impact of dandruff on patient
timeFrame: baseline
measure: Impact of dandruff on patient
timeFrame: Day 28
measure: Impact of dandruff on patient
timeFrame: Day 56
measure: Global evaluation by investigator
timeFrame: Day 28
measure: Global evaluation by investigator
timeFrame: Day 56
measure: Assessment of hair fiber and quality
timeFrame: Day 56
measure: Product respect/protects hair fiber
timeFrame: Day 56
measure: Patient product efficacy satisfaction
timeFrame: Day 28
measure: Patient product efficacy satisfaction
timeFrame: Day 56
measure: Patient product acceptability
timeFrame: Day 28
measure: Patient product acceptability
timeFrame: Day 56
measure: Patient global satisfaction
timeFrame: Day 28
measure: Patient global satisfaction
timeFrame: Day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Marta Sar Pormian
Study officials:
References: