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Completed

NCT Number: NCT05989633

DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022

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

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Key information

Conditions

Dandruff Dermatitis Scalp Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marta Sar Pormian

Warsaw, Poland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)

Other

to assess the benefit of Dercos DS in subjects with dandruff

Primary outcomes

  1. Desquamation

    Time frame: Baseline

    Scale (0=absence to 4= very severe)

  2. Desquamation

    Time frame: Day 28

    Scale (0=absence to 4= very severe)

  3. Desquamation

    Time frame: Day 56

    Scale (0=absence to 4= very severe)

  4. Irritation

    Time frame: baseline

    Scale (0=absence to 4= very severe)

  5. Irritation

    Time frame: Day 28

    Scale (0=absence to 4= very severe)

  6. Irritation

    Time frame: Day 56

    Scale (0=absence to 4= very severe)

  7. Erythema

    Time frame: baseline

    Scale (0=absence to 4= very severe)

  8. Erythema

    Time frame: Day 28

    Scale (0=absence to 4= very severe)

  9. Erythema

    Time frame: Day 56

    Scale (0=absence to 4= very severe)

  10. Itching

    Time frame: baseline

    Scale (0=absence to 10= very severe)

  11. Itching

    Time frame: Day 28

    Scale (0=absence to 10= very severe)

  12. Itching

    Time frame: Day 56

    Scale (0=absence to 10= very severe)

  13. Area involved

    Time frame: baseline

    scale from <10% to >90%

  14. Area involved

    Time frame: Day 28

    scale from <10% to >90%

  15. Area involved

    Time frame: Day 56

    scale from <10% to >90%

  16. Tolerance

    Time frame: baseline

    scale from 0= none to 5=very tolerated

  17. Tolerance

    Time frame: Day 28

    scale from 0= none to 5=very tolerated

  18. Improvement

    Time frame: Day 28

    scale from 0= worse to 5=very clearly improved

  19. Improvement

    Time frame: Day 56

    scale from 0= worse to 5=very clearly improved

  20. Impact of dandruff on patient

    Time frame: baseline

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

  21. Impact of dandruff on patient

    Time frame: Day 28

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

  22. Impact of dandruff on patient

    Time frame: Day 56

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

  23. Global evaluation by investigator

    Time frame: Day 28

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

  24. Global evaluation by investigator

    Time frame: Day 56

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

  25. Assessment of hair fiber and quality

    Time frame: Day 56

    scale from 0=worsened to 4=very improved

  26. Product respect/protects hair fiber

    Time frame: 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

    Time frame: Day 28

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

  28. Patient product efficacy satisfaction

    Time frame: Day 56

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

  29. Patient product acceptability

    Time frame: Day 28

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

  30. Patient product acceptability

    Time frame: Day 56

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

  31. Patient global satisfaction

    Time frame: Day 28

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

  32. Patient global satisfaction

    Time frame: Day 56

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

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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