A Scalp Lotion Toimprove Sensitive Scalp Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Alopecia, Sensitive Skin

Intervention / Treatment
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* Other: Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years mild alopecia: female: Ludwig type 1 male: Hamilton III to IV type Exclusion Criteria: Moderate or severe alopecia Dandruff

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pruritus | on a scale from o=none to 5=severe | Baseline | 
| pruritus | on a scale from o=none to 5=severe | Day 21 | 
| burning | on a scale from o=none to 5=severe | Baseline | 
| burning | on a scale from o=none to 5=severe | Day 21 | 
| stinging | on a scale from o=none to 5=severe | Baseline | 
| stinging | on a scale from o=none to 5=severe | Day 21 | 
| scratching | on a scale from o=none to 5=severe | Baseline | 
| scratching | on a scale from o=none to 5=severe | Day 21 | 
| hair quality | on a scale from o=none to 5=severe | Baseline | 
| hair quality | on a scale from o=none to 5=severe | Day 21 | 
| Transepidermal water loss | instrumental measurements | Baseline | 
| Transepidermal water loss | instrumental measurements | Day 21 | 
| Inflammation markers | skin swabs analysis | Baseline | 
| Inflammation markers | skin swabs analysis skin swabs analysis | Day 21 | 
| squalene | skin swabs analysis skin swabs analysis | Baseline | 
| squalene | skin swabs analysis skin swabs analysis | Day 21 | 
| Squalene monohydroperoxide | skin swabs analysis | Baseline | 
| Squalene monohydroperoxide | skin swabs analysis | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alopecia, sensitive skin, prurit