DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022 | NCT05989633

Studies
DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

NCT05989633

Sponsor

Cosmetique Active International

Status

Completed

Last Update Posted

Aug 14, 2023Actual

Enrollment

5,131Actual

Phase

Not provided

Conditions

Dandruff

Interventions

Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2022Actual

Primary Completion Date

Jun 29, 2023Actual

Completion Date

Jun 29, 2023Actual

First Submitted Date

Aug 4, 2023

First Submission Date that Met QC Criteria

Aug 4, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2023

Last Update Posted Date

Aug 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,131Actual

Name	Type	Description	Arm Group Labels	Other Names
Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)	Other	to assess the benefit of Dercos DS in subjects with dandruff

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with dandruff or seborrheic dermatitis

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012536	Scalp Dermatoses