A Scalp Lotion Toimprove Sensitive Scalp Syndrome

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630027
• Other study ID #: AC5+
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Alopecia
• Hypersensitivity
• Sensitive Skin

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