A Scalp Lotion Toimprove Sensitive Scalp Syndrome
Soothing and Anti-hair Loss Activity of a Scalp Lotion Containing Piroctone Olamine, 2,4 Diaminopyrimidine Oxide and Vichy Mineralizing Water
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
November 18, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedNovember 29, 2022
November 1, 2022
1.5 years
November 18, 2022
November 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
erythema
on a scale from o=none to 5=severe
Baseline
erythema
on a scale from o=none to 5=severe
Day 21
inflammation
on a scale from o=none to 5=severe
Baseline
inflammation
on a scale from o=none to 5=severe
Day 21
greasiness
on a scale from o=none to 5=severe
Baseline
greasiness
on a scale from o=none to 5=severe
Day 21
Global soothing score
sum of the symptoms with a score up to 15
Baseline
Global soothing score
sum of the symptoms with a score up to 15
Day 21
Secondary Outcomes (18)
pruritus
Baseline
pruritus
Day 21
burning
Baseline
burning
Day 21
stinging
Baseline
- +13 more secondary outcomes
Interventions
observational, prospective study
Eligibility Criteria
Adult subjects with mild alopecia and no dandruff
You may qualify if:
- \>18 years
- mild alopecia:
- female: Ludwig type 1
- male: Hamilton III to IV type
You may not qualify if:
- Moderate or severe alopecia
- Dandruff
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
L'OREAL Research and Innovation
Saint-Ouen, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Philippe Massiot
L'OREAL Research and Innovation, Saint-Ouen, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2022
First Posted
November 29, 2022
Study Start
January 2, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
November 29, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share