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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05630027
Other study ID # AC5+
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2019
Est. completion date June 30, 2020

Study information

Verified date November 2022
Source Cosmetique Active International
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - >18 years - mild alopecia: - female: Ludwig type 1 - male: Hamilton III to IV type Exclusion Criteria: - Moderate or severe alopecia - Dandruff

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing water
observational, prospective study

Locations

Country Name City State
France L'OREAL Research and Innovation Saint-Ouen

Sponsors (1)

Lead Sponsor Collaborator
Cosmetique Active International

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary erythema on a scale from o=none to 5=severe Baseline
Primary erythema on a scale from o=none to 5=severe Day 21
Primary inflammation on a scale from o=none to 5=severe Baseline
Primary inflammation on a scale from o=none to 5=severe Day 21
Primary greasiness on a scale from o=none to 5=severe Baseline
Primary greasiness on a scale from o=none to 5=severe Day 21
Primary Global soothing score sum of the symptoms with a score up to 15 Baseline
Primary Global soothing score sum of the symptoms with a score up to 15 Day 21
Secondary pruritus on a scale from o=none to 5=severe Baseline
Secondary pruritus on a scale from o=none to 5=severe Day 21
Secondary burning on a scale from o=none to 5=severe Baseline
Secondary burning on a scale from o=none to 5=severe Day 21
Secondary stinging on a scale from o=none to 5=severe Baseline
Secondary stinging on a scale from o=none to 5=severe Day 21
Secondary scratching on a scale from o=none to 5=severe Baseline
Secondary scratching on a scale from o=none to 5=severe Day 21
Secondary hair quality on a scale from o=none to 5=severe Baseline
Secondary hair quality on a scale from o=none to 5=severe Day 21
Secondary Transepidermal water loss instrumental measurements Baseline
Secondary Transepidermal water loss instrumental measurements Day 21
Secondary Inflammation markers skin swabs analysis Baseline
Secondary Inflammation markers skin swabs analysis skin swabs analysis Day 21
Secondary squalene skin swabs analysis skin swabs analysis Baseline
Secondary squalene skin swabs analysis skin swabs analysis Day 21
Secondary Squalene monohydroperoxide skin swabs analysis Baseline
Secondary Squalene monohydroperoxide skin swabs analysis Day 21
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