DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

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

Study Overview

• Status: Completed
• Conditions: Dandruff
• Intervention / Treatment: Other: Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)

• Study Type: Observational
• Enrollment (Actual): 5131

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Marta Sar Pormian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects with dandruff or seborrheic dermatitis

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desquamation	Scale (0=absence to 4= very severe)	Baseline
Desquamation	Scale (0=absence to 4= very severe)	Day 28
Desquamation	Scale (0=absence to 4= very severe)	Day 56
Irritation	Scale (0=absence to 4= very severe)	baseline
Irritation	Scale (0=absence to 4= very severe)	Day 28
Irritation	Scale (0=absence to 4= very severe)	Day 56
Erythema	Scale (0=absence to 4= very severe)	baseline
Erythema	Scale (0=absence to 4= very severe)	Day 28
Erythema	Scale (0=absence to 4= very severe)	Day 56
Itching	Scale (0=absence to 10= very severe)	baseline
Itching	Scale (0=absence to 10= very severe)	Day 28
Itching	Scale (0=absence to 10= very severe)	Day 56
Area involved	scale from <10% to >90%	baseline
Area involved	scale from <10% to >90%	Day 28
Area involved	scale from <10% to >90%	Day 56
Tolerance	scale from 0= none to 5=very tolerated	baseline
Tolerance	scale from 0= none to 5=very tolerated	Day 28
Improvement	scale from 0= worse to 5=very clearly improved	Day 28
Improvement	scale from 0= worse to 5=very clearly improved	Day 56
Impact of dandruff on patient	Scale from 0=not bothered at all to 5=very bothered	baseline
Impact of dandruff on patient	Scale from 0=not bothered at all to 5=very bothered	Day 28
Impact of dandruff on patient	Scale from 0=not bothered at all to 5=very bothered	Day 56
Global evaluation by investigator	Scale from 0=not at all satisfactory at all to 4=very satisfactory	Day 28
Global evaluation by investigator	Scale from 0=not at all satisfactory at all to 4=very satisfactory	Day 56
Assessment of hair fiber and quality	scale from 0=worsened to 4=very improved	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	Day 56
Patient product efficacy satisfaction	questionnare with scale ranging from 0=completely disagree to 5=completely agree	Day 28
Patient product efficacy satisfaction	questionnare with scale ranging from 0=completely disagree to 5=completely agree	Day 56
Patient product acceptability	scale ranging from 0=not satisfied at all to 10=very satisfied	Day 28
Patient product acceptability	scale ranging from 0=not satisfied at all to 10=very satisfied	Day 56
Patient global satisfaction	scale ranging from 0=not satisfied at all to 10=very satisfied	Day 28
Patient global satisfaction	scale ranging from 0=not satisfied at all to 10=very satisfied	Day 56

Collaborators and Investigators

• Sponsor: Cosmetique Active International

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: treatment satisfaction; dandruff
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Scalp Dermatoses; Dandruff; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenium
• Other Study ID Numbers: Dercos DS in Dandruff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No