DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

Dandruff Clinical Trial

Official title:

DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05989633
• Other study ID #: Dercos DS in Dandruff
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Dandruff

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