A Scalp Lotion Toimprove Sensitive Scalp Syndrome

Sponsor
Cosmetique Active International (Industry)
Overall Status
Completed
CT.gov ID
NCT05630027
Collaborator
(none)
100
1
17.9
5.6

Study Details

Study Description

Brief Summary

Overall, 100 Caucasian subjects participated in this 6-weeks lasting study, AC5+ was applied daily. All subjects had clinically confirmed mild to moderate alopecia and self-declared sensitive scalp. Instrumental assessments included Trans Epidermal Water Loss (TEWL), inflammation markers, clinical assessments included the severity of erythema, inflammation and greasiness. Subjective/Self assessments comprised the intensity of the scalp itch/pruritus and the evaluation of their head hair status (volume, abundance, strength). Same assessments were provided by the investigators.

Condition or Disease Intervention/Treatment Phase
  • Other: Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing water

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Soothing and Anti-hair Loss Activity of a Scalp Lotion Containing Piroctone Olamine, 2,4 Diaminopyrimidine Oxide and Vichy Mineralizing Water
Actual Study Start Date :
Jan 2, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Outcome Measures

Primary Outcome Measures

  1. erythema [Baseline]

    on a scale from o=none to 5=severe

  2. erythema [Day 21]

    on a scale from o=none to 5=severe

  3. inflammation [Baseline]

    on a scale from o=none to 5=severe

  4. inflammation [Day 21]

    on a scale from o=none to 5=severe

  5. greasiness [Baseline]

    on a scale from o=none to 5=severe

  6. greasiness [Day 21]

    on a scale from o=none to 5=severe

  7. Global soothing score [Baseline]

    sum of the symptoms with a score up to 15

  8. Global soothing score [Day 21]

    sum of the symptoms with a score up to 15

Secondary Outcome Measures

  1. pruritus [Baseline]

    on a scale from o=none to 5=severe

  2. pruritus [Day 21]

    on a scale from o=none to 5=severe

  3. burning [Baseline]

    on a scale from o=none to 5=severe

  4. burning [Day 21]

    on a scale from o=none to 5=severe

  5. stinging [Baseline]

    on a scale from o=none to 5=severe

  6. stinging [Day 21]

    on a scale from o=none to 5=severe

  7. scratching [Baseline]

    on a scale from o=none to 5=severe

  8. scratching [Day 21]

    on a scale from o=none to 5=severe

  9. hair quality [Baseline]

    on a scale from o=none to 5=severe

  10. hair quality [Day 21]

    on a scale from o=none to 5=severe

  11. Transepidermal water loss [Baseline]

    instrumental measurements

  12. Transepidermal water loss [Day 21]

    instrumental measurements

  13. Inflammation markers [Baseline]

    skin swabs analysis

  14. Inflammation markers [Day 21]

    skin swabs analysis skin swabs analysis

  15. squalene [Baseline]

    skin swabs analysis skin swabs analysis

  16. squalene [Day 21]

    skin swabs analysis skin swabs analysis

  17. Squalene monohydroperoxide [Baseline]

    skin swabs analysis

  18. Squalene monohydroperoxide [Day 21]

    skin swabs analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 18 years

  • mild alopecia:

  • female: Ludwig type 1

  • male: Hamilton III to IV type

Exclusion Criteria:
  • Moderate or severe alopecia

  • Dandruff

Contacts and Locations

Locations

Site City State Country Postal Code
1 L'OREAL Research and Innovation Saint-Ouen France

Sponsors and Collaborators

  • Cosmetique Active International

Investigators

  • Study Director: Philippe Massiot, L'OREAL Research and Innovation, Saint-Ouen, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cosmetique Active International
ClinicalTrials.gov Identifier:
NCT05630027
Other Study ID Numbers:
  • AC5+
First Posted:
Nov 29, 2022
Last Update Posted:
Nov 29, 2022
Last Verified:
Nov 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2022