Dandruff Clinical Trial
Official title:
DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
Verified date | August 2023 |
Source | Cosmetique Active International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS
Status | Completed |
Enrollment | 5131 |
Est. completion date | June 29, 2023 |
Est. primary completion date | June 29, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Marta Sar Pormian | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Cosmetique Active International |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Desquamation | Scale (0=absence to 4= very severe) | Baseline | |
Primary | Desquamation | Scale (0=absence to 4= very severe) | Day 28 | |
Primary | Desquamation | Scale (0=absence to 4= very severe) | Day 56 | |
Primary | Irritation | Scale (0=absence to 4= very severe) | baseline | |
Primary | Irritation | Scale (0=absence to 4= very severe) | Day 28 | |
Primary | Irritation | Scale (0=absence to 4= very severe) | Day 56 | |
Primary | Erythema | Scale (0=absence to 4= very severe) | baseline | |
Primary | Erythema | Scale (0=absence to 4= very severe) | Day 28 | |
Primary | Erythema | Scale (0=absence to 4= very severe) | Day 56 | |
Primary | Itching | Scale (0=absence to 10= very severe) | baseline | |
Primary | Itching | Scale (0=absence to 10= very severe) | Day 28 | |
Primary | Itching | Scale (0=absence to 10= very severe) | Day 56 | |
Primary | Area involved | scale from <10% to >90% | baseline | |
Primary | Area involved | scale from <10% to >90% | Day 28 | |
Primary | Area involved | scale from <10% to >90% | Day 56 | |
Primary | Tolerance | scale from 0= none to 5=very tolerated | baseline | |
Primary | Tolerance | scale from 0= none to 5=very tolerated | Day 28 | |
Primary | Improvement | scale from 0= worse to 5=very clearly improved | Day 28 | |
Primary | Improvement | scale from 0= worse to 5=very clearly improved | Day 56 | |
Primary | Impact of dandruff on patient | Scale from 0=not bothered at all to 5=very bothered | baseline | |
Primary | Impact of dandruff on patient | Scale from 0=not bothered at all to 5=very bothered | Day 28 | |
Primary | Impact of dandruff on patient | Scale from 0=not bothered at all to 5=very bothered | Day 56 | |
Primary | Global evaluation by investigator | Scale from 0=not at all satisfactory at all to 4=very satisfactory | Day 28 | |
Primary | Global evaluation by investigator | Scale from 0=not at all satisfactory at all to 4=very satisfactory | Day 56 | |
Primary | Assessment of hair fiber and quality | scale from 0=worsened to 4=very improved | Day 56 | |
Primary | 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 | Day 56 | |
Primary | Patient product efficacy satisfaction | questionnare with scale ranging from 0=completely disagree to 5=completely agree | Day 28 | |
Primary | Patient product efficacy satisfaction | questionnare with scale ranging from 0=completely disagree to 5=completely agree | Day 56 | |
Primary | Patient product acceptability | scale ranging from 0=not satisfied at all to 10=very satisfied | Day 28 | |
Primary | Patient product acceptability | scale ranging from 0=not satisfied at all to 10=very satisfied | Day 56 | |
Primary | Patient global satisfaction | scale ranging from 0=not satisfied at all to 10=very satisfied | Day 28 | |
Primary | Patient global satisfaction | scale ranging from 0=not satisfied at all to 10=very satisfied | Day 56 |
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