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Completed

NCT Number: NCT05630027

A Scalp Lotion Toimprove Sensitive Scalp Syndrome

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.

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Key information

Conditions

Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sensitive Skin Skin Diseases Skin and Connective Tissue Diseases

Study type

Observational

Primary location

L'OREAL Research and Innovation

Saint-Ouen, France

Who can participate

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

Inclusion criteria

  • >18 years
  • mild alopecia:
  • female: Ludwig type 1
  • male: Hamilton III to IV type

Exclusion criteria

  • Moderate or severe alopecia
  • Dandruff

Treatment and study plan

Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing water

Other

observational, prospective study

Primary outcomes

  1. erythema

    Time frame: Baseline

    on a scale from o=none to 5=severe

  2. erythema

    Time frame: Day 21

    on a scale from o=none to 5=severe

  3. inflammation

    Time frame: Baseline

    on a scale from o=none to 5=severe

  4. inflammation

    Time frame: Day 21

    on a scale from o=none to 5=severe

  5. greasiness

    Time frame: Baseline

    on a scale from o=none to 5=severe

  6. greasiness

    Time frame: Day 21

    on a scale from o=none to 5=severe

  7. Global soothing score

    Time frame: Baseline

    sum of the symptoms with a score up to 15

  8. Global soothing score

    Time frame: Day 21

    sum of the symptoms with a score up to 15

Secondary outcomes

  1. pruritus

    Time frame: Baseline

    on a scale from o=none to 5=severe

  2. pruritus

    Time frame: Day 21

    on a scale from o=none to 5=severe

  3. burning

    Time frame: Baseline

    on a scale from o=none to 5=severe

  4. burning

    Time frame: Day 21

    on a scale from o=none to 5=severe

  5. stinging

    Time frame: Baseline

    on a scale from o=none to 5=severe

  6. stinging

    Time frame: Day 21

    on a scale from o=none to 5=severe

  7. scratching

    Time frame: Baseline

    on a scale from o=none to 5=severe

  8. scratching

    Time frame: Day 21

    on a scale from o=none to 5=severe

  9. hair quality

    Time frame: Baseline

    on a scale from o=none to 5=severe

  10. hair quality

    Time frame: Day 21

    on a scale from o=none to 5=severe

  11. Transepidermal water loss

    Time frame: Baseline

    instrumental measurements

  12. Transepidermal water loss

    Time frame: Day 21

    instrumental measurements

  13. Inflammation markers

    Time frame: Baseline

    skin swabs analysis

  14. Inflammation markers

    Time frame: Day 21

    skin swabs analysis skin swabs analysis

  15. squalene

    Time frame: Baseline

    skin swabs analysis skin swabs analysis

  16. squalene

    Time frame: Day 21

    skin swabs analysis skin swabs analysis

  17. Squalene monohydroperoxide

    Time frame: Baseline

    skin swabs analysis

  18. Squalene monohydroperoxide

    Time frame: Day 21

    skin swabs analysis

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

Soothing and Anti-hair Loss Activity of a Scalp Lotion Containing Piroctone Olamine, 2,4 Diaminopyrimidine Oxide and Vichy Mineralizing Water

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2022
Registry last updated
Nov 29, 2022

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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