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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05989633
Other study ID # Dercos DS in Dandruff
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 4, 2022
Est. completion date June 29, 2023

Study information

Verified date August 2023
Source Cosmetique Active International
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)
to assess the benefit of Dercos DS in subjects with dandruff

Locations

Country Name City State
Poland Marta Sar Pormian Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Cosmetique Active International

Country where clinical trial is conducted

Poland, 

Outcome

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
See also
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Completed NCT02448082 - The Efficacy of Sodium Shale Oil Sulponate 1% Shampoo in the Treatment of Pityriasis Capitis Phase 2
Completed NCT06436495 - Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects N/A
Recruiting NCT05319444 - Cleansing Device for the Treatment of Scalp and Hair Conditions N/A
Completed NCT06052241 - Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics N/A