NCT05989633

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,131

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

August 4, 2023

Last Update Submit

August 4, 2023

Conditions

Keywords

dandrufftreatment satisfaction

Outcome Measures

Primary Outcomes (32)

  • 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

Interventions

to assess the benefit of Dercos DS in subjects with dandruff

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with dandruff or seborrheic dermatitis

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marta Sar Pormian

Warsaw, Poland

Location

MeSH Terms

Conditions

Dandruff

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesScalp Dermatoses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

July 4, 2022

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations