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DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

Sponsor
Cosmetique Active International (Industry)
Overall Status
Completed
CT.gov ID
NCT05989633
Collaborator
(none)
5,131
Enrollment
1
Location
11.8
Actual Duration (Months)
433.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)

Study Design

Study Type:
Observational
Actual Enrollment :
5131 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022
Actual Study Start Date :
Jul 4, 2022
Actual Primary Completion Date :
Jun 29, 2023
Actual Study Completion Date :
Jun 29, 2023

Outcome Measures

Primary Outcome Measures

  1. Desquamation [Baseline]

    Scale (0=absence to 4= very severe)

  2. Desquamation [Day 28]

    Scale (0=absence to 4= very severe)

  3. Desquamation [Day 56]

    Scale (0=absence to 4= very severe)

  4. Irritation [baseline]

    Scale (0=absence to 4= very severe)

  5. Irritation [Day 28]

    Scale (0=absence to 4= very severe)

  6. Irritation [Day 56]

    Scale (0=absence to 4= very severe)

  7. Erythema [baseline]

    Scale (0=absence to 4= very severe)

  8. Erythema [Day 28]

    Scale (0=absence to 4= very severe)

  9. Erythema [Day 56]

    Scale (0=absence to 4= very severe)

  10. Itching [baseline]

    Scale (0=absence to 10= very severe)

  11. Itching [Day 28]

    Scale (0=absence to 10= very severe)

  12. Itching [Day 56]

    Scale (0=absence to 10= very severe)

  13. Area involved [baseline]

    scale from <10% to >90%

  14. Area involved [Day 28]

    scale from <10% to >90%

  15. Area involved [Day 56]

    scale from <10% to >90%

  16. Tolerance [baseline]

    scale from 0= none to 5=very tolerated

  17. Tolerance [Day 28]

    scale from 0= none to 5=very tolerated

  18. Improvement [Day 28]

    scale from 0= worse to 5=very clearly improved

  19. Improvement [Day 56]

    scale from 0= worse to 5=very clearly improved

  20. Impact of dandruff on patient [baseline]

    Scale from 0=not bothered at all to 5=very bothered

  21. Impact of dandruff on patient [Day 28]

    Scale from 0=not bothered at all to 5=very bothered

  22. Impact of dandruff on patient [Day 56]

    Scale from 0=not bothered at all to 5=very bothered

  23. Global evaluation by investigator [Day 28]

    Scale from 0=not at all satisfactory at all to 4=very satisfactory

  24. Global evaluation by investigator [Day 56]

    Scale from 0=not at all satisfactory at all to 4=very satisfactory

  25. Assessment of hair fiber and quality [Day 56]

    scale from 0=worsened to 4=very improved

  26. Product respect/protects hair fiber [Day 56]

    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

  27. Patient product efficacy satisfaction [Day 28]

    questionnare with scale ranging from 0=completely disagree to 5=completely agree

  28. Patient product efficacy satisfaction [Day 56]

    questionnare with scale ranging from 0=completely disagree to 5=completely agree

  29. Patient product acceptability [Day 28]

    scale ranging from 0=not satisfied at all to 10=very satisfied

  30. Patient product acceptability [Day 56]

    scale ranging from 0=not satisfied at all to 10=very satisfied

  31. Patient global satisfaction [Day 28]

    scale ranging from 0=not satisfied at all to 10=very satisfied

  32. Patient global satisfaction [Day 56]

    scale ranging from 0=not satisfied at all to 10=very satisfied

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marta Sar Pormian Warsaw Poland

Sponsors and Collaborators

  • Cosmetique Active International

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cosmetique Active International
ClinicalTrials.gov Identifier:
NCT05989633
Other Study ID Numbers:
  • Dercos DS in Dandruff
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cosmetique Active International
dandruff
treatment satisfaction
Additional relevant MeSH terms:
Dandruff
Selenium

Study Results

No Results Posted as of Aug 14, 2023