Alopecia Clinical Trial
Official title:
Soothing and Anti-hair Loss Activity of a Scalp Lotion Containing Piroctone Olamine, 2,4 Diaminopyrimidine Oxide and Vichy Mineralizing Water
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 |
Verified date | November 2022 |
Source | Cosmetique Active International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | L'OREAL Research and Innovation | Saint-Ouen |
Lead Sponsor | Collaborator |
---|---|
Cosmetique Active International |
France,
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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